Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices, 57029-57030 [2019-23205]

Download as PDF Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices 25–26, 2019, to discuss the long-term benefits and risks of breast implants indicated for breast augmentation and reconstruction. FDA learned from presentations at the March 2019 panel meeting, and through comments submitted to the associated public docket, that some patients may not be receiving or understanding important information regarding the benefits and risks of breast implants in a format that allows them to make a well-informed decision about whether or not to have a breast implantation. For these reasons, FDA is now providing recommendations concerning the content and format of certain labeling information for these devices. Specifically, FDA is recommending that manufacturers incorporate a boxed warning and a patient decision checklist into the labeling for these devices to better ensure certain information is received and understood by patients. This draft guidance also recommends updated and additional labeling information, including updates to the silicone gel-filled breast implant rupture screening recommendations, inclusion of an easy-to-find description of materials, and provision of patient device cards that were recommended at the March 2019 panel meeting. This draft guidance is not intended to include a complete listing of all labeling components for breast implants. When finalized, the recommendations in this draft guidance will supplement or in some cases replace recommendations in FDA’s guidance entitled ‘‘Saline, Silicone Gel, and Alternative Breast Implants’’ (November 2006) (https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/salinesilicone-gel-and-alternative-breastimplants). Based on the information presented at the March 2019 panel meeting, FDA continues to gather available information regarding the benefits and risks associated with different types of breast implants, and consider appropriate labeling and regulatory requirements for them. FDA will continue to analyze all available information regarding the risks associated with breast implants and take additional actions as determined necessary or appropriate. FDA invites comments on the benefits and risks of smooth and textured breast implants, respectively, as well as the labeling recommendations for these implants. the requirements of the applicable statutes and regulations. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Breast Implants—Certain Labeling Recommendations to Improve Patient Communication.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies IV. Paperwork Reduction Act of 1995 Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Breast Implants—Certain Labeling Recommendations to Improve Patient Communication’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19021 to identify the guidance you are requesting. This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: OMB control No. Topic 814, subparts A through E ....................... 812 ............................................................ 801 ............................................................ 50, 56 ........................................................ 830 ............................................................ 820 ............................................................ Premarket approval ...................................................................................................... Investigational Device Exemption ................................................................................ Medical Device Labeling Regulations .......................................................................... Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ Unique Device Identification System ........................................................................... Current Good Manufacturing Practice (CGMP); Quality System Regulation .............. [FR Doc. 2019–23197 Filed 10–23–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0557] BILLING CODE 4164–01–P Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices khammond on DSKJM1Z7X2PROD with NOTICES III. Electronic Access 21 CFR Part; guidance; or FDA form Dated: October 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. 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 SUMMARY: VerDate Sep<11>2014 17:34 Oct 23, 2019 Jkt 250001 57029 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 0910–0231 0910–0078 0910–0485 0910–0755 0910–0720 0910–0073 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 November 25, 2019. 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 0910–0449. Also include the FDA docket number found in brackets in the heading of this document. E:\FR\FM\24OCN1.SGM 24OCN1 57030 Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices Postmarket Surveillance of Medical Devices—21 CFR part 822 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. OMB Control Number 0910–0449— Extension In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers, so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with §§ 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with § 822.38. Respondents to this collection of information are those manufacturers that require PS of their products. In the Federal Register of June 19, 2019 (84 FR 28554), 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 respondents Activity/21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours PS submission (822.9 and 822.10) ..................................... Changes to PS plan after approval (822.21) ....................... Changes to PS plan for a device that is no longer marketed (822.28) .................................................................. Waiver (822.29) ................................................................... Exemption request (822.30) ................................................ Periodic reports (822.38) ..................................................... 25 9 1 1 25 9 120 40 3,000 360 6 1 16 25 1 1 1 3 6 1 16 75 8 40 40 40 48 40 640 3,000 Total .............................................................................. ........................ ........................ ........................ ........................ 7,088 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Reporting Burden Estimate: The burden captured in table 1 is based on the data from FDA’s internal tracking system. Sections 822.26, 822.27, and 822.34 do not constitute information collection subject to review under the PRA because it entails no burden other than that necessary to identify the respondent, the date, the respondent’s address, and the nature of the instrument (see 5 CFR 1320.3(h)(1)). TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity/21 CFR section Total annual records Average burden per recordkeeping Total hours Manufacturer records (822.31) ............................................ Investigator records (822.32) ............................................... 25 75 1 1 25 75 20 5 500 375 Total .............................................................................. ........................ ........................ ........................ ........................ 875 1 There khammond on DSKJM1Z7X2PROD with NOTICES Number of records per recordkeeper are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Recordkeeping Burden Estimate: FDA expects that at least some of the manufacturers will be able to satisfy the PS requirement using information or data they already have. For purposes of calculating burden, however, FDA has assumed that each PS order can only be satisfied by a 3-year clinically based surveillance plan, using three investigators. These estimates are based on FDA’s knowledge and experience with PS. Our estimated burden for the information collection reflects a decrease of 29,982 hours. We attribute VerDate Sep<11>2014 17:34 Oct 23, 2019 Jkt 250001 this adjustment to a decrease in the number of submissions we received over the last few years. Dated: October 10, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23205 Filed 10–23–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0825] Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\24OCN1.SGM Notice. 24OCN1

Agencies

[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57029-57030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23205]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0557]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Postmarket 
Surveillance of Medical Devices

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 
November 25, 2019.

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 0910-0449. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 57030]]


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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Postmarket Surveillance of Medical Devices--21 CFR part 822

OMB Control Number 0910-0449--Extension

    Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360l) authorizes FDA to require a manufacturer to conduct postmarket 
surveillance (PS) of any device that meets the criteria set forth in 
the statute. The PS regulation establishes procedures that FDA uses to 
approve and disapprove PS plans. The regulation provides instructions 
to manufacturers, so they know what information is required in a PS 
plan submission. FDA reviews PS plan submissions in accordance with 
Sec. Sec.  822.15 through 822.19 of the regulation, which describe the 
grounds for approving or disapproving a PS plan. In addition, the PS 
regulation provides instructions to manufacturers to submit interim and 
final reports in accordance with Sec.  822.38. Respondents to this 
collection of information are those manufacturers that require PS of 
their products.
    In the Federal Register of June 19, 2019 (84 FR 28554), 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                        Average
     Activity/21 CFR section         Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
PS submission (822.9 and 822.10)              25               1              25             120           3,000
Changes to PS plan after                       9               1               9              40             360
 approval (822.21)..............
Changes to PS plan for a device                6               1               6               8              48
 that is no longer marketed
 (822.28).......................
Waiver (822.29).................               1               1               1              40              40
Exemption request (822.30)......              16               1              16              40             640
Periodic reports (822.38).......              25               3              75              40           3,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,088
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Explanation of Reporting Burden Estimate: The burden captured in 
table 1 is based on the data from FDA's internal tracking system. 
Sections 822.26, 822.27, and 822.34 do not constitute information 
collection subject to review under the PRA because it entails no burden 
other than that necessary to identify the respondent, the date, the 
respondent's address, and the nature of the instrument (see 5 CFR 
1320.3(h)(1)).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturer records (822.31)...              25               1              25              20             500
Investigator records (822.32)...              75               1              75               5             375
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             875
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Explanation of Recordkeeping Burden Estimate: FDA expects that at 
least some of the manufacturers will be able to satisfy the PS 
requirement using information or data they already have. For purposes 
of calculating burden, however, FDA has assumed that each PS order can 
only be satisfied by a 3-year clinically based surveillance plan, using 
three investigators. These estimates are based on FDA's knowledge and 
experience with PS.
    Our estimated burden for the information collection reflects a 
decrease of 29,982 hours. We attribute this adjustment to a decrease in 
the number of submissions we received over the last few years.

    Dated: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23205 Filed 10-23-19; 8:45 am]
 BILLING CODE 4164-01-P

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