Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification, 14223-14224 [2017-05300]

Download as PDF 14223 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Information collection activity Number of respondents Number of responses per respondent Total annual responses Hours per response Total hours 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. Leslie Kux, Associate Commissioner for Policy. Premarket Notification—21 CFR Part 807, Subpart E [FR Doc. 2017–05293 Filed 3–16–17; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: 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 oira_ submission@omb.eop.gov. 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. ADDRESSES: 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. asabaliauskas on DSK3SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 20:02 Mar 16, 2017 Jkt 241001 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 § 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 HDEs. Under § 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 § 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 § 807.93 (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the 510(k) submission, § 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 § 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 § 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 E:\FR\FM\17MRN1.SGM 17MRN1 14224 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices 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 responses per respondent Number of respondents Average burden per response Total annual responses Activity and 21 CFR part/section Form FDA No. 510(k) submission (807 subpart E) ...... Summary cover sheet (807.87) ............ Status request (807.90(a)(3)) ............... Standards (807.87(d) and (f)) ............... 510(k) statement (807.93) .................... ........................ 3514 3541 3654 ........................ 3,900 1,956 218 2,700 225 1 1 1 1 10 3,900 1,956 218 2,700 2,250 79 ..................... .5 (30 minutes) .25 (15 minutes) 10 ..................... 10 ..................... 308,100 978 55 27,000 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. 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0762. Also include the FDA docket number found in brackets in the heading of this document. [FR Doc. 2017–05300 Filed 3–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. 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. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration [Docket No. FDA–2013–D–0117] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: 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: ADDRESSES: asabaliauskas on DSK3SPTVN1PROD with NOTICES Total hours VerDate Sep<11>2014 20:02 Mar 16, 2017 Jkt 241001 Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910–0762— Extension The guidance document entitled ‘‘Providing Information About Pediatric Uses of Medical Devices—Guidance for Industry and Food and Drug Administration Staff’’ suggests that applicants who submit certain medical device applications include, if readily available, pediatric use information for diseases or conditions that the device is being used to treat, diagnose, or cure that are outside the device’s approved or proposed indications for use, as well as an estimate of the number of pediatric patients with such diseases or PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 conditions. The information submitted will allow FDA to identify pediatric uses of devices outside their approved or proposed indication for use to determine areas where further pediatric device development could be useful. This recommendation applies to applicants who submit the following applications: (1) Any request for a humanitarian device exemption submitted under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)); (2) any premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the FD&C Act (21 U.S.C. 360e); and (3) any product development protocol submitted under section 515 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 of the FD&C Act will choose to submit this information and that it will take 30 minutes for them to do so. In the Federal Register of December 5, 2016 (81 FR 87575), 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: E:\FR\FM\17MRN1.SGM 17MRN1

Agencies

[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14223-14224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.

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