81 FR 81772 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 223 (November 18, 2016)

Page Range		81772-81774
FR Document		2016-27851

The Food and Drug Administration (FDA) 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 medical device premarket notification.

Federal Register, Volume 81 Issue 223 (Friday, November 18, 2016)

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81772-81774]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the

[[Page 81773]]

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 medical device premarket notification.

DATES: Submit either electronic or written comments on the collection 
of information by January 17, 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-2013-N-0804 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Premarket Notification.'' 
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: http://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, [email protected].

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.

Premarket Notification--21 CFR Part 807, Subpart E OMB Control Number 
0910-0120--Extension

    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) requires 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

[[Page 81774]]

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 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.
    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 No.            Number of     responses per   Total annual    Average  burden per  response   Total  hours
                                                            respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart    ......................           3,900               1           3,900  79............................         308,100
 E).
Summary cover sheet (807.87)....  FDA 3514..............           1,956               1           1,956  0.5 (30 minutes)..............             978
Status request (807.90(a)(3))...  FDA 3541..............             218               1             218  0.25 (15 minutes).............              55
Standards (807.87(d) and (f))...  FDA 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: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27851 Filed 11-17-16; 8:45 am]
 BILLING CODE 4164-01-P

81774 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices

device exemption (HDE), petition for the 510(k) as required by § 807.92 submissions including premarket
Evaluation of Automatic Class III (510(k) summary) or a statement notifications or other requirements. FDA
Designation (de novo), or be reclassified certifying that the submitter will make has published and updated the list of
into class I or class II before being available upon request the information recognized standards regularly since
marketed. FDA makes the final decision in the 510(k) with certain exceptions as enactment of FDAMA and has allowed
of whether a device is substantially per § 807.93 (510(k) statement). If the 510(k) submitters to certify conformance
equivalent or not equivalent. 510(k) submitter includes a 510(k) to recognized standards to meet the
Section 807.81 states when a statement in the 510(k) submission, requirements of § 807.87. Form FDA
premarket notification is required. A § 807.93 requires that the official 3654, the 510(k) Standards Data Form,
premarket notification is required to be correspondent of the firm make standardizes the format for submitting
submitted by a person who is: (1) available within 30 days of a request all information on consensus standards that
Introducing a device to the market for information included in the submitted a 510(k) submitter chooses to use as a
the first time; (2) introducing a device premarket notification on safety and portion of their premarket notification
into commercial distribution for the first effectiveness. This information will be submission (Form FDA 3654 is not for
time by a person who is required to provided to any person within 30 days declarations of conformance to a
register; and (3) introducing or of a request if the device described in recognized standard). FDA believes that
reintroducing a device which is the 510(k) submission is determined to use of this form will simplify the 510(k)
significantly changed or modified in be substantially equivalent. The preparation and review process for
design, components, method of information provided will be a 510(k).
manufacturer, or the intended use that duplicate of the 510(k) submission Under § 807.90, submitters may
could affect the safety and effectiveness including any safety and effectiveness request information on their 510(k)
of the device. information, but excluding all patient review status 90 days after the initial
Form FDA 3514, a summary cover identifiers and trade secret and login date of the 510(k). Thereafter, the
sheet form, assists respondents in commercial confidential information. submitter may request status reports
categorizing administrative 510(k) Section 204 of the Food and Drug every 30 days following the initial status
information for submission to FDA. This Administration Modernization Act request. To obtain a 510(k) status report,
form also assists respondents in (FDAMA) (Pub. L. 105–115) amended the submitter should complete the
categorizing information for other FDA section 514 of the FD&C Act (21 U.S.C. status request form, Form FDA 3541,
medical device programs such as PMAs, 360d). Amended section 514 allows and fax it to the Center for Devices and
investigational device exemptions, and FDA to recognize consensus standards Radiological Health office identified on
HDEs. Under § 807.87(h), each 510(k) developed by international and national the form.
submitter must include in the 510(k) organizations for use in satisfying FDA estimates the burden of this
either a summary of the information in portions of device premarket review collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual Total
Activity and 21 CFR Part/Section Form No. responses per burden per
respondents responses hours
respondent response

510(k) submission (807 subpart ........................ 3,900 1 3,900 79 .............................. 308,100
E).
Summary cover sheet (807.87) ... FDA 3514 ...... 1,956 1 1,956 0.5 (30 minutes) ........ 978
Status request (807.90(a)(3)) ...... FDA 3541 ...... 218 1 218 0.25 (15 minutes) ...... 55
Standards (807.87(d) and (f)) ...... FDA 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: November 15, 2016. DEPARTMENT OF HEALTH AND Fee Amendments of 2012: Questions
Leslie Kux, HUMAN SERVICES and Answers Related to User Fee
Associate Commissioner for Policy. Assessments.’’ This guidance provides
Food and Drug Administration updated answers to common questions
[FR Doc. 2016–27851 Filed 11–17–16; 8:45 am]
BILLING CODE 4164–01–P [Docket No. FDA–2012–D–0880] from the generic drug industry and
other interested parties involved in the
Generic Drug User Fee Amendments of development and/or testing of generic
2012: Questions and Answers Related drug products regarding GDUFA user
to User Fee Assessments; Guidance fees and finalizes the revised version of
for Industry; Availability the guidance.
Food and Drug Administration,
mstockstill on DSK3G9T082PROD with NOTICES

AGENCY: DATES: Submit either electronic or
HHS. written comments on Agency guidances
ACTION: Notice of availability. at any time.
SUMMARY: The Food and Drug ADDRESSES: You may submit comments
Administration (FDA or Agency) is as follows:
announcing the availability of guidance
for industry entitled ‘‘Generic Drug User

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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		Submit either electronic or written comments on the collection of information by January 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		81 FR 81772

81 FR 81772 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 223 (November 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration