Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure, 91181-91183 [2016-30243]
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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 Division of Dockets
Management. 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 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Office of
Policy, Office of Policy, Planning,
Legislation, and Analysis, Food and
Drug Administration, Bldg. 32, Rm.
4238, 10903 New Hampshire Ave.,
Silver Spring, MD, 20993. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Robert Berlin, Office of Policy, Office of
Policy, Planning, Legislation, and
VerDate Sep<11>2014
18:42 Dec 15, 2016
Jkt 241001
Analysis, Food and Drug
Administration, Bldg. 32, Rm. 4238,
10903 New Hampshire Ave., Silver
Spring, MD, 20993, 301–796–8828,
robert.berlin@fda.hhs.gov. Alternate
contact: Office of Policy, 301–796–4830.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for the public and FDA staff
entitled ‘‘Gifts to FDA: Evaluation and
Acceptance.’’ The Secretary of HHS has
the authority to accept conditional or
unconditional gifts on behalf of the
United States. The Secretary has
delegated this gift authority to the
Commissioner of Food and Drugs. This
guidance provides the process and
principles we will use in implementing
this authority.
FDA will consider gifts from all
sources except the Reagan-Udall
Foundation (RUF) on a case-by-case
basis using a balancing test, described in
the guidance. While any person may
offer a gift, there are five reasons we
should reject a gift without additional
evaluation. We should not accept a gift
if: (1) The donor imposes conditions
that are illegal, are contrary to public
policy, are unreasonable to administer,
are contrary to FDA’s current policies
and procedures, or are contrary to
generally accepted public standards; (2)
the donor requires us to provide the
donor with some privilege, concession,
or other present or future benefit in
return for the gift; (3) a debarred entity
offers the gift; (4) a different authority or
financial mechanism applies; or (5) the
total costs associated with acceptance
are expected to exceed the cost of
purchasing a similar item and the cost
of normal care and maintenance.
In the Federal Register of June 29,
2016 (81 FR 42365), FDA announced the
availability of a draft guidance entitled
‘‘Gifts to FDA: Evaluation and
Acceptance: Evaluation and
Acceptance.’’ FDA received one
comment expressing concern regarding
the policy described in the guidance. It
appears the commenter may have
misunderstood the policy and
incorrectly believed that gifts would not
be limited, would be unreported, and
would be provided to Federal
employees themselves. As explained in
the guidance, that is not the case.
Rather, the recipients of any gifts would
be the Agency, gifts are extensively
reviewed to ensure receipt would be
appropriate, and the Agency intends to
publish a summary of received gifts.
The Agency has made only minor
changes to the guidance to clarify that
the evaluation of gifts from RUF will
reflect RUF’s unique role in support of
PO 00000
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91181
the Agency and the statutory safeguards
in 21 U.S.C. 379dd. In addition, the
discussion of restrictions on funds for
travel has been clarified to better reflect
the scope of statutes and policies
governing the use of non-Agency funds
for travel.
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 this matter. 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 with access to the Internet
may obtain the guidance at either https://
www.fda.gov/RegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30312 Filed 12–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3995]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Pediatric Uses of Devices;
Requirement for Submission of
Information on Pediatric
Subpopulations That Suffer From a
Disease or Condition That a Device Is
Intended To Treat, Diagnose, or Cure
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with the
requirement for submission of
information on pediatric subpopulations
SUMMARY:
E:\FR\FM\16DEN1.SGM
16DEN1
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Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
that suffer from a disease or condition
that a device is intended to treat,
diagnose, or cure.
DATES: Submit either electronic or
written comments on the collection of
information by February 14, 2017.
ADDRESSES: You may submit comments
as follows:
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’’).
mstockstill on DSK3G9T082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 No. FDA–
2016–N–3995 for ‘‘Medical Devices;
Pediatric Uses of Devices; Requirement
for Submission of Information on
Pediatric Subpopulations That Suffer
From a Disease or Condition That a
Device Is Intended to Treat, Diagnose, or
Cure.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
VerDate Sep<11>2014
18:42 Dec 15, 2016
Jkt 241001
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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 Division of Dockets
Management. 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 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
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Fmt 4703
Sfmt 4703
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Devices; Pediatric Uses of
Devices; Requirement for Submission of
Information on Pediatric
Subpopulations That Suffer From a
Disease or Condition That a Device Is
Intended To Treat, Diagnose, or Cure—
21 CFR Part 814—OMB Control
Number 0910–0748—Extension
Section 515A(a) of the FD&C Act
requires applicants who submit certain
medical device applications to include
readily available information providing
a description of any pediatric
subpopulations that suffer from the
disease or condition that the device is
intended to treat, diagnose, or cure, and
the number of affected pediatric
patients. The information submitted
will allow FDA to track the number of
approved devices for which there is a
pediatric subpopulation that suffers
from the disease or condition that the
device is intended to treat, diagnose, or
cure and the review time for each such
device application.
These requirements apply to
applicants who submit humanitarian
device exemption requests (HDEs),
premarket approval applications (PMAs)
or PMA supplements, or a product
development protocol (PDP).
FDA expects to receive approximately
45 original PMA/PDP/HDE applications
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Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
each year, 5 of which FDA expects to be
HDEs. This estimate is based on the
average of FDA’s receipt of new PMA
applications. The Agency estimates that
10 of the estimated 40 original PMA
submissions will fail to provide the
required pediatric use information and
their sponsors will therefore be required
to submit PMA amendments. The
Agency also expects to receive
approximately 700 supplements that
will include the pediatric use
Furthermore, because supplements may
include readily available information on
pediatric populations by referencing a
previous submission, FDA estimates the
average time to obtain and submit the
required information in a supplement to
be 2 hours. FDA estimates that the total
estimated burden is 1,760 hours.
FDA estimates the burden of this
collection of information as follows:
information required by section 515A(a)
of the FD&C Act and part 814 (21 CFR
part 814).
All that is required is to gather,
organize, and submit information that is
readily available, using any approach
that meets the requirements of section
515A(a) of the FD&C Act and part 814.
We believe that because the applicant is
required to organize and submit only
readily available information, no more
than 8 hours will be required to comply.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity/21 CFR section
Pediatric
Pediatric
Pediatric
Pediatric
in
in
in
in
Total annual
responses
Average
burden per
response
Total hours
an original PMA or PDP—814.20(b)(13)
a PMA amendment—814.37(b)(2) ..........
a PMA supplement—814.39(c)(2) ...........
an HDE—814.104(b)(6) ...........................
30
10
700
5
1
1
1
1
30
10
700
5
8
8
2
8
240
80
1,400
40
Total ........................................................................................
......................
........................
......................
......................
1,760
1 There
information
information
information
information
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Dated: December 12, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–30243 Filed 12–15–16; 8:45 am]
[FR Doc. 2016–30398 Filed 12–15–16; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
mstockstill on DSK3G9T082PROD with NOTICES
Extension of Effective Date of NIH
Policy on the Use of a Single
Institutional Review Board for MultiSite Research
The National Institutes of Health
(NIH) is extending the effective date of
the NIH Policy on the Use of a Single
Institutional Review Board for MultiSite Research from May 25, 2017, to
September 25, 2017. A copy of the NIH
Policy was published in the Federal
Register on June 21, 2016 (81 FR 40325).
See https://www.gpo.gov/fdsys/pkg/FR2016-06-21/pdf/2016-14513.pdf.
Guidance and Frequently Asked
Questions to assist in the
implementation of the policy will soon
be available at https://osp.od.nih.gov/
office-clinical-research-and-bioethicspolicy/clinical-research-policy/modelsirb-review.
For further information contact the
NIH Office of Science Policy,
Telephone: 301–496–9838, Email:
SingleIRBPolicy@mail.nih.gov.
VerDate Sep<11>2014
18:42 Dec 15, 2016
Jkt 241001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council on Alcohol
Abuse and Alcoholism.
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
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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: February 9, 2017.
Closed: 9:00 a.m. to 9:30 a.m.
Agenda: BSC Report: Evaluation of the
NIAAA Intramural Program.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
Conference Rooms, Bethesda, MD 20892.
Closed: 9:40 a.m. to 10:50 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
Conference Rooms, Bethesda, MD 20892.
Open: 11:00 a.m. to 3:15 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
Conference Rooms, Bethesda, MD 20892.
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room
2085, Rockville, MD 20852, 301–443–9737
bautista@mail.nih.gov.
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.niaaa.nih.gov/AboutNIAAA/
AdvisoryCouncil/Pages/default.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
E:\FR\FM\16DEN1.SGM
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Agencies
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91181-91183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3995]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Pediatric Uses of Devices;
Requirement for Submission of Information on Pediatric Subpopulations
That Suffer From a Disease or Condition That a Device Is Intended To
Treat, Diagnose, or Cure
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the requirement for submission of information on
pediatric subpopulations
[[Page 91182]]
that suffer from a disease or condition that a device is intended to
treat, diagnose, or cure.
DATES: Submit either electronic or written comments on the collection
of information by February 14, 2017.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 No.
FDA-2016-N-3995 for ``Medical Devices; Pediatric Uses of Devices;
Requirement for Submission of Information on Pediatric Subpopulations
That Suffer From a Disease or Condition That a Device Is Intended to
Treat, Diagnose, or Cure.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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 Division of Dockets Management. 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 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission
of Information on Pediatric Subpopulations That Suffer From a Disease
or Condition That a Device Is Intended To Treat, Diagnose, or Cure--21
CFR Part 814--OMB Control Number 0910-0748--Extension
Section 515A(a) of the FD&C Act requires applicants who submit
certain medical device applications to include readily available
information providing a description of any pediatric subpopulations
that suffer from the disease or condition that the device is intended
to treat, diagnose, or cure, and the number of affected pediatric
patients. The information submitted will allow FDA to track the number
of approved devices for which there is a pediatric subpopulation that
suffers from the disease or condition that the device is intended to
treat, diagnose, or cure and the review time for each such device
application.
These requirements apply to applicants who submit humanitarian
device exemption requests (HDEs), premarket approval applications
(PMAs) or PMA supplements, or a product development protocol (PDP).
FDA expects to receive approximately 45 original PMA/PDP/HDE
applications
[[Page 91183]]
each year, 5 of which FDA expects to be HDEs. This estimate is based on
the average of FDA's receipt of new PMA applications. The Agency
estimates that 10 of the estimated 40 original PMA submissions will
fail to provide the required pediatric use information and their
sponsors will therefore be required to submit PMA amendments. The
Agency also expects to receive approximately 700 supplements that will
include the pediatric use information required by section 515A(a) of
the FD&C Act and part 814 (21 CFR part 814).
All that is required is to gather, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the FD&C Act and part 814. We
believe that because the applicant is required to organize and submit
only readily available information, no more than 8 hours will be
required to comply. Furthermore, because supplements may include
readily available information on pediatric populations by referencing a
previous submission, FDA estimates the average time to obtain and
submit the required information in a supplement to be 2 hours. FDA
estimates that the total estimated burden is 1,760 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Pediatric information in an original PMA 30 1 30 8 240
or PDP--814.20(b)(13)...................
Pediatric information in a PMA amendment-- 10 1 10 8 80
814.37(b)(2)............................
Pediatric information in a PMA 700 1 700 2 1,400
supplement--814.39(c)(2)................
Pediatric information in an HDE-- 5 1 5 8 40
814.104(b)(6)...........................
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Total................................ ............ .............. ............ ............ 1,760
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30243 Filed 12-15-16; 8:45 am]
BILLING CODE 4164-01-P