Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Information on Pediatric Uses of Medical Devices, 65986-65988 [2019-25980]
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65986
Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4590]
Morton Grove Pharmaceuticals, Inc., et
al.; Withdrawal of Approval of 21
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of 21 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
January 2, 2020.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 040759 ........
Phenytoin Sodium Capsules, 30milligrams (mg) (Extended)
ANDA 062349 ........
Nystatin Oral Suspension, 100,000 units/milliters (mL) ........
ANDA 062483 ........
Griseofulvin V (griseofulvin microsize) Oral Suspension,
125 mg/5 mL.
Amikacin Sulfate Injection USP, Equivalent to (EQ) 250 mg
base/mL.
Amantadine Hydrochloride (HCl) Syrup USP, 50 mg/5 mL ..
Cimetidine HCl Oral Solution, EQ 300 mg base/5 mL ..........
Sotalol HCl Tablets USP 80 mg, 120 mg, 160 mg, and 240
mg.
Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg
Fentanyl Extended-Release Film, 25 micrograms (mcg)/hr,
50 mcg/hr, 75 mcg/hr, 100 mcg/hr.
Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton
Grove, IL 60053.
G&W Laboratories, Inc., 301 Helen St., South Plainfield, NJ
07080.
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
G&W Laboratories, Inc.
Do.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple
Grove, MN 55369.
Do.
Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc, 577 Chipeta Way, Salt Lake City, UT
84108.
G&W Laboratories, Inc.
Mayne Pharma LLC, 1240 Sugg Parkway, Greenville, NC
27834.
Morton Grove Pharmaceuticals Inc.
Do.
Do.
ANDA 063264 ........
ANDA 072655 ........
ANDA 074176 ........
ANDA 075366 ........
ANDA 075887 ........
ANDA 076709 ........
ANDA 076841 ........
ANDA 077062 ........
ANDA 078426 ........
ANDA 078653 ........
ANDA 078701 ........
ANDA 078884 ........
ANDA 087811 ........
ANDA 088761 ........
ANDA 088762 ........
ANDA 090786 ........
ANDA 091267 ........
ANDA 201947 ........
Mesalamine Enema, 4 grams (gm)/60 mL ............................
Fentanyl Extended-Release Film, 25 mcg/hr, 50 mcg/hr, 75
mcg/hr, and 100 mcg/hr.
Zolpidem Tartrate Tablets, 5 mg and 10 mg .........................
Ranitidine HCl Tablets USP, EQ 150 mg base .....................
Ranitidine HCl Tablets USP, EQ 150 mg base and EQ 300
mg base.
Ranitidine HCl Tablets USP, EQ 75 mg base .......................
Phrenilin (acetaminophen and butalbital) Tablets, 325 mg/
50 mg.
Prometh VC Plain (promethazine HCl and phenylephrine
HCl) Syrup, 5 mg/5mL, and 6.25 mg/5 mL.
Prometh w/Dextromethorphan (promethazine HCl and
dextromethorphan hydrobromide) Syrup, 6.25 mg/5 mL
and 15 mg/5 mL.
Carbidopa, Entacapone, and Levodopa Tablets, 12.5 mg/
200 mg/50 mg.
Donepezil HCl Tablets, 5 mg and 10 mg ..............................
Morphine Sulfate Oral Solution, 10 mg/5 mL and 20 mg/5
mL.
Do.
Bausch Health US, LLC.
G&W Laboratories, Inc.
Do.
Morton Grove Pharmaceuticals Inc.
Do.
VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771.
jbell on DSKJLSW7X2PROD with NOTICES
Do = Ditto.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 2,
2020. Approval of each entire
application is withdrawn, including any
strengths or products inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
VerDate Sep<11>2014
17:10 Nov 29, 2019
Jkt 250001
products that are listed in the table that
are in inventory on January 2, 2020 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3995]
[FR Doc. 2019–25946 Filed 11–29–19; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Submission of
Information on Pediatric Uses of
Medical Devices
BILLING CODE 4164–01–P
AGENCY:
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
PO 00000
Food and Drug Administration,
HHS.
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Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices
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 (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
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 January 31, 2020.
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 January 31,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 31, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:10 Nov 29, 2019
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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 No. FDA–
2016–N–3995 for ‘‘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, 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
https://www.regulations.gov or at the
Dockets Management Staff 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 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 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
65987
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), 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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02DEN1.SGM
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65988
Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices
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 Under Section 515A of the
Federal Food, Drug, and Cosmetic
Act—21 CFR 814
OMB Control Number 0910–0748—
Extension
Section 515A(a) of the Food, Drug,
and Cosmetic Act (21 U.S.C. 360e–1)
(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 amendments or supplements, or
a product development protocol (PDP).
FDA expects to receive approximately
47 original PMA/PDP/HDE applications
each year, 1 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
11 of the estimated 47 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 928 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.
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Pediatric information in an original PMA or PDP—
814.20(b)(13) ....................................................................
Pediatric information in a PMA amendment—814.37(b)(2)
Pediatric
information
in
a
PMA
supplement—
814.39(c)(2)(i) ...................................................................
Pediatric information in an HDE—814.104(b)(6) .................
Pediatric information for uses outside approved indication
11
5
1
1
11
5
8
8
88
40
928
1
800
1
1
1
928
1
800
2
8
.5
1,856
8
400
Total ..............................................................................
........................
........................
........................
........................
2,392
1 There
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
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 is a supplement to
be 2 hours. FDA estimates that the total
estimated burden is 2,392 hours.
Additionally, the guidance document
entitled ‘‘Providing Information About
Pediatric Uses of Medical Devices—
Guidance for Industry and Food and
Drug Administration Staff’’ describes
how to compile and submit the readily
available pediatric use information
required under section 515A(a) 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(a)
of the FD&C Act will choose to submit
this information and that it will take 30
minutes for them to do so.
FDA estimates the burden of this
collection of information as follows:
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden and
corresponding responses reflect the
requirements under section 515A(a) of
the FD&C Act, in addition to the
submission of data related to pediatric
uses outside an approved indication, as
described in the guidance document
entitled ‘‘Providing Information About
Pediatric Uses of Medical Devices—
Guidance for Industry and Food and
Drug Administration Staff.’’ OMB
previously approved the information
collection related to uses outside an
approved indication under OMB control
number 0910–0762. As the information
collection uses the same data and relies
upon the same legal authority as OMB
control number 0910–0748, we have
discontinued OMB control number
0910–0762 and merged the information
collection accordingly. Additionally, we
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17:10 Nov 29, 2019
Jkt 250001
have altered the title of the collection to
reflect all collections of pediatric uses.
Our estimated burden for the
information collection reflects an
overall increase of 632 hours and a
corresponding increase of supplements
and of uses outside of approved
indications. We attribute this
adjustment to an increase in the number
of supplements we received over the
last 5 years and merging data from
discontinued OMB control number
0910–0762.
Dated: November 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25980 Filed 11–29–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Health Center Patient Survey,
OMB No. 0915–0368—Reinstatement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
SUMMARY:
E:\FR\FM\02DEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 65986-65988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3995]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission of Information on Pediatric Uses of Medical
Devices
AGENCY: Food and Drug Administration, HHS.
[[Page 65987]]
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
(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
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 January 31, 2020.
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 January 31, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 31, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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 No.
FDA-2016-N-3995 for ``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, 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 https://www.regulations.gov or at the Dockets Management Staff 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 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 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.gpo.gov/fdsys/pkg/FR-2015-09-18/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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
[[Page 65988]]
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 Under Section 515A of
the Federal Food, Drug, and Cosmetic Act--21 CFR 814
OMB Control Number 0910-0748--Extension
Section 515A(a) of the Food, Drug, and Cosmetic Act (21 U.S.C.
360e-1) (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 amendments or supplements, or a product development
protocol (PDP).
FDA expects to receive approximately 47 original PMA/PDP/HDE
applications each year, 1 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 11 of the estimated 47 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 928
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 is a supplement to be 2 hours. FDA
estimates that the total estimated burden is 2,392 hours.
Additionally, the guidance document entitled ``Providing
Information About Pediatric Uses of Medical Devices--Guidance for
Industry and Food and Drug Administration Staff'' describes how to
compile and submit the readily available pediatric use information
required under section 515A(a) 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(a) of the FD&C Act will choose to submit this
information and that it will take 30 minutes for them to do so.
FDA estimates the burden of this collection of information as
follows:
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pediatric information in an 11 1 11 8 88
original PMA or PDP--
814.20(b)(13)..................
Pediatric information in a PMA 5 1 5 8 40
amendment--814.37(b)(2)........
Pediatric information in a PMA 928 1 928 2 1,856
supplement--814.39(c)(2)(i)....
Pediatric information in an HDE-- 1 1 1 8 8
814.104(b)(6)..................
Pediatric information for uses 800 1 800 .5 400
outside approved indication....
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Total....................... .............. .............. .............. .............. 2,392
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden and corresponding responses reflect the
requirements under section 515A(a) of the FD&C Act, in addition to the
submission of data related to pediatric uses outside an approved
indication, as described in the guidance document entitled ``Providing
Information About Pediatric Uses of Medical Devices--Guidance for
Industry and Food and Drug Administration Staff.'' OMB previously
approved the information collection related to uses outside an approved
indication under OMB control number 0910-0762. As the information
collection uses the same data and relies upon the same legal authority
as OMB control number 0910-0748, we have discontinued OMB control
number 0910-0762 and merged the information collection accordingly.
Additionally, we have altered the title of the collection to reflect
all collections of pediatric uses.
Our estimated burden for the information collection reflects an
overall increase of 632 hours and a corresponding increase of
supplements and of uses outside of approved indications. We attribute
this adjustment to an increase in the number of supplements we received
over the last 5 years and merging data from discontinued OMB control
number 0910-0762.
Dated: November 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25980 Filed 11-29-19; 8:45 am]
BILLING CODE 4164-01-P
