82 FR 14223 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 51 (March 17, 2017)

Page Range		14223-14224
FR Document		2017-05300

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 51 (Friday, March 17, 2017)

[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14223-14224]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0804]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Premarket 
Notification

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0120. 
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.

Premarket Notification--21 CFR Part 807, Subpart E

OMB Control Number 0910-0120--Reinstatement

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360(k)) and the implementing regulation under part 
807 (21 CFR part 807, subpart E) require a person who intends to market 
a medical device to submit a premarket notification submission to FDA 
at least 90 days before proposing to begin the introduction, or 
delivery for introduction into interstate commerce, for commercial 
distribution of a device intended for human use. Based on the 
information provided in the notification, FDA must determine whether 
the new device is substantially equivalent to a legally marketed 
device, as defined in Sec.  807.92(a)(3) (21 CFR 807.92(a)(3)). If the 
device is determined to be not substantially equivalent to a legally 
marketed device, it must have an approved premarket approval 
application (PMA), product development protocol, humanitarian device 
exemption (HDE), petition for Evaluation of Automatic Class III 
Designation (de novo), or be reclassified into class I or class II 
before being marketed. FDA makes the final decision of whether a device 
is substantially equivalent or not equivalent.
    Section 807.81 states when a premarket notification is required. A 
premarket notification is required to be submitted by a person who is: 
(1) Introducing a device to the market for the first time; (2) 
introducing a device into commercial distribution for the first time by 
a person who is required to register; and (3) introducing or 
reintroducing a device which is significantly changed or modified in 
design, components, method of manufacturer, or the intended use that 
could affect the safety and effectiveness of the device.
    Form FDA 3514, a summary cover sheet form, assists respondents in 
categorizing administrative 510(k) information for submission to FDA. 
This form also assists respondents in categorizing information for 
other FDA medical device programs such as PMAs, investigational device 
exemptions, and HDEs. Under Sec.  807.87(h), each 510(k) submitter must 
include in the 510(k) either a summary of the information in the 510(k) 
as required by Sec.  807.92 (510(k) summary) or a statement certifying 
that the submitter will make available upon request the information in 
the 510(k) with certain exceptions as per Sec.  807.93 (510(k) 
statement). If the 510(k) submitter includes a 510(k) statement in the 
510(k) submission, Sec.  807.93 requires that the official 
correspondent of the firm make available within 30 days of a request 
all information included in the submitted premarket notification on 
safety and effectiveness. This information will be provided to any 
person within 30 days of a request if the device described in the 
510(k) submission is determined to be substantially equivalent. The 
information provided will be a duplicate of the 510(k) submission 
including any safety and effectiveness information, but excluding all 
patient identifiers and trade secret and commercial confidential 
information.
    Section 204 of the Food and Drug Administration Modernization Act 
(FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act (21 
U.S.C. 360d). Amended section 514 allows FDA to recognize consensus 
standards developed by international and national organizations for use 
in satisfying portions of device premarket review submissions including 
premarket notifications or other requirements. FDA has published and 
updated the list of recognized standards regularly since enactment of 
FDAMA and has allowed 510(k) submitters to certify conformance to 
recognized standards to meet the requirements of Sec.  807.87. Form FDA 
3654, the 510(k) Standards Data Form, standardizes the format for 
submitting information on consensus standards that a 510(k) submitter 
chooses to use as a portion of their premarket notification submission 
(Form FDA 3654 is not for declarations of conformance to a recognized 
standard). FDA believes that use of this form will simplify the 510(k) 
preparation and review process for 510(k).
    Under Sec.  807.90, submitters may request information on their 
510(k) review status 90 days after the initial login date of the 
510(k). Thereafter, the

[[Page 14224]]

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
    Activity and 21 CFR part/section      Form FDA No.      Number of     responses per   Total annual     Average burden per  response     Total hours
                                                           respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart E)......  ..............           3,900               1           3,900  79.............................         308,100
Summary cover sheet (807.87)...........            3514           1,956               1           1,956  .5 (30 minutes)................             978
Status request (807.90(a)(3))..........            3541             218               1             218  .25 (15 minutes)...............              55
Standards (807.87(d) and (f))..........            3654           2,700               1           2,700  10.............................          27,000
510(k) statement (807.93)..............  ..............             225              10           2,250  10.............................          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.
[FR Doc. 2017-05300 Filed 3-16-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices 14223

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
Information collection activity responses per Total hours
respondents responses response
respondent

Voluntary Genomic Data Submissions ................................ 1 1 1 50 50
1 There are no capital costs or operating and maintenance costs associated with this collection.

Dated: March 13, 2017. Premarket Notification—21 CFR Part HDEs. Under § 807.87(h), each 510(k)
Leslie Kux, 807, Subpart E submitter must include in the 510(k)
Associate Commissioner for Policy. either a summary of the information in
OMB Control Number 0910–0120—
[FR Doc. 2017–05293 Filed 3–16–17; 8:45 am] the 510(k) as required by § 807.92
Reinstatement
BILLING CODE 4164–01–P
(510(k) summary) or a statement
Section 510(k) of the Federal Food, certifying that the submitter will make
Drug, and Cosmetic Act (the FD&C Act) available upon request the information
DEPARTMENT OF HEALTH AND (21 U.S.C. 360(k)) and the implementing in the 510(k) with certain exceptions as
HUMAN SERVICES regulation under part 807 (21 CFR part per § 807.93 (510(k) statement). If the
807, subpart E) require a person who 510(k) submitter includes a 510(k)
Food and Drug Administration intends to market a medical device to statement in the 510(k) submission,
submit a premarket notification § 807.93 requires that the official
[Docket No. FDA–2013–N–0804] submission to FDA at least 90 days correspondent of the firm make
before proposing to begin the available within 30 days of a request all
Agency Information Collection introduction, or delivery for information included in the submitted
Activities; Submission for Office of introduction into interstate commerce, premarket notification on safety and
Management and Budget Review; for commercial distribution of a device effectiveness. This information will be
Comment Request; Premarket intended for human use. Based on the provided to any person within 30 days
Notification information provided in the of a request if the device described in
notification, FDA must determine the 510(k) submission is determined to
AGENCY: Food and Drug Administration, whether the new device is substantially be substantially equivalent. The
HHS. equivalent to a legally marketed device, information provided will be a
ACTION: Notice. as defined in § 807.92(a)(3) (21 CFR duplicate of the 510(k) submission
807.92(a)(3)). If the device is determined including any safety and effectiveness
SUMMARY: The Food and Drug to be not substantially equivalent to a information, but excluding all patient
Administration (FDA) is announcing legally marketed device, it must have an identifiers and trade secret and
that a proposed collection of approved premarket approval commercial confidential information.
information has been submitted to the application (PMA), product Section 204 of the Food and Drug
Office of Management and Budget development protocol, humanitarian Administration Modernization Act
(OMB) for review and clearance under device exemption (HDE), petition for (FDAMA) (Pub. L. 105–115) amended
the Paperwork Reduction Act of 1995. Evaluation of Automatic Class III section 514 of the FD&C Act (21 U.S.C.
DATES: Fax written comments on the Designation (de novo), or be reclassified 360d). Amended section 514 allows
collection of information by April 17, into class I or class II before being FDA to recognize consensus standards
2017. marketed. FDA makes the final decision developed by international and national
ADDRESSES: To ensure that comments on of whether a device is substantially organizations for use in satisfying
the information collection are received, equivalent or not equivalent. portions of device premarket review
OMB recommends that written Section 807.81 states when a submissions including premarket
comments be faxed to the Office of premarket notification is required. A notifications or other requirements. FDA
Information and Regulatory Affairs, premarket notification is required to be has published and updated the list of
OMB, Attn: FDA Desk Officer, FAX: submitted by a person who is: (1) recognized standards regularly since
202–395–7285, or emailed to oira_ Introducing a device to the market for enactment of FDAMA and has allowed
submission@omb.eop.gov. All the first time; (2) introducing a device 510(k) submitters to certify conformance
comments should be identified with the into commercial distribution for the first to recognized standards to meet the
OMB control number 0910–0120. Also time by a person who is required to requirements of § 807.87. Form FDA
include the FDA docket number found register; and (3) introducing or 3654, the 510(k) Standards Data Form,
in brackets in the heading of this reintroducing a device which is standardizes the format for submitting
document. significantly changed or modified in information on consensus standards that
design, components, method of a 510(k) submitter chooses to use as a
FOR FURTHER INFORMATION CONTACT: FDA manufacturer, or the intended use that portion of their premarket notification
PRA Staff, Office of Operations, Food could affect the safety and effectiveness submission (Form FDA 3654 is not for
and Drug Administration, Three White of the device. declarations of conformance to a
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Flint North 10A63, 11601 Landsdown Form FDA 3514, a summary cover recognized standard). FDA believes that
St., North Bethesda, MD 20852, sheet form, assists respondents in use of this form will simplify the 510(k)
PRAStaff@fda.hhs.gov. categorizing administrative 510(k) preparation and review process for
SUPPLEMENTARY INFORMATION: In information for submission to FDA. This 510(k).
compliance with 44 U.S.C. 3507, FDA form also assists respondents in Under § 807.90, submitters may
has submitted the following proposed categorizing information for other FDA request information on their 510(k)
collection of information to OMB for medical device programs such as PMAs, review status 90 days after the initial
review and clearance. investigational device exemptions, and login date of the 510(k). Thereafter, the

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14224 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices

submitter may request status reports and fax it to the Center for Devices and comment on the proposed collection of
every 30 days following the initial status Radiological Health office identified on information. No comments were
request. To obtain a 510(k) status report, the form. received.
the submitter should complete the In the Federal Register of November
FDA estimates the burden of this
status request form, Form FDA 3541, 18, 2016 (81 FR 81772), FDA published
collection of information as follows:
a 60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity and 21 CFR part/section Form FDA No. responses per burden per Total hours
respondents responses
respondent response

510(k) submission (807 subpart E) ...... ........................ 3,900 1 3,900 79 ..................... 308,100
Summary cover sheet (807.87) ............ 3514 1,956 1 1,956 .5 (30 minutes) 978
Status request (807.90(a)(3)) ............... 3541 218 1 218 .25 (15 minutes) 55
Standards (807.87(d) and (f)) ............... 3654 2,700 1 2,700 10 ..................... 27,000
510(k) statement (807.93) .................... ........................ 225 10 2,250 10 ..................... 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. 202–395–7285, or emailed to oira_ conditions. The information submitted
Leslie Kux, submission@omb.eop.gov. All will allow FDA to identify pediatric
Associate Commissioner for Policy. comments should be identified with the uses of devices outside their approved
[FR Doc. 2017–05300 Filed 3–16–17; 8:45 am] OMB control number 0910–0762. Also or proposed indication for use to
BILLING CODE 4164–01–P
include the FDA docket number found determine areas where further pediatric
in brackets in the heading of this device development could be useful.
document. This recommendation applies to
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA applicants who submit the following
HUMAN SERVICES PRA Staff, Office of Operations, Food applications: (1) Any request for a
and Drug Administration, Three White humanitarian device exemption
Food and Drug Administration submitted under section 520(m) of the
Flint North 10A–12M, 11601
[Docket No. FDA–2013–D–0117] Landsdown St., North Bethesda, MD Federal Food, Drug, and Cosmetic Act
20852, PRAStaff@fda.hhs.gov. (the FD&C Act) (21 U.S.C. 360j(m)); (2)
Agency Information Collection any premarket approval application
SUPPLEMENTARY INFORMATION: In
Activities; Submission for Office of (PMA) or supplement to a PMA
compliance with 44 U.S.C. 3507, FDA submitted under section 515 of the
Management and Budget Review; has submitted the following proposed
Comment Request; Providing FD&C Act (21 U.S.C. 360e); and (3) any
collection of information to OMB for product development protocol
Information About Pediatric Uses of review and clearance.
Medical Devices submitted under section 515 of the
Providing Information About Pediatric FD&C Act.
AGENCY: Food and Drug Administration, Uses of Medical Devices Under Section Respondents are permitted to submit
HHS. 515A of the Federal Food, Drug, and information relating to uses of the
ACTION: Notice. Cosmetic Act device outside the approved or
proposed indication if such uses are
SUMMARY: The Food and Drug OMB Control Number 0910–0762— described or acknowledged in
Administration (FDA) is announcing Extension acceptable sources of readily available
that a proposed collection of
The guidance document entitled information. We estimate that 20
information has been submitted to the
‘‘Providing Information About Pediatric percent of respondents submitting
Office of Management and Budget
Uses of Medical Devices—Guidance for information required by section 515A of
(OMB) for review and clearance under
Industry and Food and Drug the FD&C Act will choose to submit this
the Paperwork Reduction Act of 1995.
Administration Staff’’ suggests that information and that it will take 30
DATES: Fax written comments on the applicants who submit certain medical minutes for them to do so.
collection of information by April 17, device applications include, if readily In the Federal Register of December 5,
2017. available, pediatric use information for 2016 (81 FR 87575), FDA published a
ADDRESSES: To ensure that comments on diseases or conditions that the device is 60-day notice requesting public
the information collection are received, being used to treat, diagnose, or cure comment on the proposed collection of
OMB recommends that written that are outside the device’s approved or information. No comments were
comments be faxed to the Office of proposed indications for use, as well as received.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Information and Regulatory Affairs, an estimate of the number of pediatric FDA estimates the burden of this
OMB, Attn: FDA Desk Officer, FAX: patients with such diseases or collection of information as follows:

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Document Created: 2017-03-17 02:49:10
Document Modified: 2017-03-17 02:49:10

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 17, 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 14223

82 FR 14223 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 51 (March 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration