82 FR 13825 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 49 (March 15, 2017)

Page Range		13825-13825
FR Document		2017-05096

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.

Federal Register, Volume 82 Issue 49 (Wednesday, March 15, 2017)

[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Page 13825]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05096]



[[Page 13825]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3995]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 
14, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-0748. 
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, [email protected].

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; 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

OMB Control Number 0910-0748--Extension

    Section 515A(a) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360e-1) 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 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.
    In the Federal Register of December 16, 2016 (81 FR 91181), 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
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Pediatric information in an                   30               1              30               8             240
 original PMA or PDP--
 814.20(b)(13)..................
Pediatric information in a PMA                10               1              10               8              80
 amendment--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)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,760
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05096 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13825

DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA FDA expects to receive approximately
HUMAN SERVICES PRA Staff, Office of Operations, Food 45 original PMA/PDP/HDE applications
and Drug Administration, Three White each year, 5 of which FDA expects to be
Food and Drug Administration Flint North 10A63, 11601 Landsdown HDEs. This estimate is based on the
[Docket No. FDA–2016–N–3995] St., North Bethesda, MD 20852, average of FDA’s receipt of new PMA
PRAStaff@fda.hhs.gov. applications. The Agency estimates that
Agency Information Collection SUPPLEMENTARY INFORMATION: In 10 of the estimated 40 original PMA
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA submissions will fail to provide the
Management and Budget Review; has submitted the following proposed required pediatric use information and
Comment Request; Medical Devices; collection of information to OMB for their sponsors will therefore be required
Pediatric Uses of Devices; review and clearance. to submit PMA amendments. The
Requirement for Submission of Medical Devices; Pediatric Uses of Agency also expects to receive
Information on Pediatric Devices; Requirement for Submission of approximately 700 supplements that
Subpopulations That Suffer From a Information on Pediatric will include the pediatric use
Disease or Condition That a Device Is Subpopulations That Suffer From a information required by section 515A(a)
Intended To Treat, Diagnose, or Cure Disease or Condition That a Device Is of the FD&C Act and part 814 (21 CFR
AGENCY: Food and Drug Administration, Intended To Treat, Diagnose, or Cure part 814).
HHS. OMB Control Number 0910–0748— All that is required is to gather,
ACTION: Notice. Extension organize, and submit information that is
Section 515A(a) of the Federal Food, readily available, using any approach
SUMMARY: The Food and Drug that meets the requirements of section
Administration (FDA) is announcing Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360e–1) requires applicants 515A(a) of the FD&C Act and part 814.
that a proposed collection of We believe that because the applicant is
information has been submitted to the who submit certain medical device
applications to include readily available required to organize and submit only
Office of Management and Budget
information providing a description of readily available information, no more
(OMB) for review and clearance under
any pediatric subpopulations that suffer than 8 hours will be required to comply.
the Paperwork Reduction Act of 1995.
from the disease or condition that the Furthermore, because supplements may
DATES: Fax written comments on the
device is intended to treat, diagnose, or include readily available information on
collection of information by April 14, pediatric populations by referencing a
cure, and the number of affected
2017.
pediatric patients. The information previous submission, FDA estimates the
ADDRESSES: To ensure that comments on submitted will allow FDA to track the average time to obtain and submit the
the information collection are received, number of approved devices for which required information in a supplement to
OMB recommends that written there is a pediatric subpopulation that be 2 hours. FDA estimates that the total
comments be faxed to the Office of suffers from the disease or condition estimated burden is 1,760 hours.
Information and Regulatory Affairs, that the device is intended to treat,
In the Federal Register of December
OMB, Attn: FDA Desk Officer, FAX: diagnose, or cure and the review time
202–395–7285, or emailed to oira_ 16, 2016 (81 FR 91181), FDA published
for each such device application.
submission@omb.eop.gov. All These requirements apply to a 60-day notice requesting public
comments should be identified with the applicants who submit humanitarian comment on the proposed collection of
OMB control number 0910–0748. Also device exemption requests (HDEs), information. No comments were
include the FDA docket number found premarket approval applications (PMAs) received.
in brackets in the heading of this or PMA supplements, or a product FDA estimates the burden of this
document. development protocol (PDP). collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response

Pediatric information in an original PMA or PDP—
814.20(b)(13) .................................................................... 30 1 30 8 240
Pediatric information in a PMA amendment—814.37(b)(2) 10 1 10 8 80
Pediatric information in a PMA supplement—814.39(c)(2) 700 1 700 2 1,400
Pediatric information in an HDE—814.104(b)(6) ................. 5 1 5 8 40

Total .............................................................................. ........................ ........................ ........................ ........................ 1,760
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSK3SPTVN1PROD with NOTICES2

Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05096 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P

VerDate Sep<11>2014 18:19 Mar 14, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 9990 E:\FR\FM\15MRN1.SGM 15MRN1

Document Created: 2017-03-15 06:04:41
Document Modified: 2017-03-15 06:04:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by April 14, 2017.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		82 FR 13825

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 49 (March 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration