Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices, 72063-72066 [2016-25232]

Download as PDF Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices sradovich on DSK3GMQ082PROD with NOTICES for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human biologic product PLEGRIDY (peginterferon beta–1a). PLEGRIDY is indicated for treatment of patients with relapsing forms of multiple sclerosis. Subsequent to this approval, the USPTO received patent term restoration applications for PLEGRIDY (U.S. Patent Nos. 7,446,173; 8,017,733; and 8,524,660) from Biogen Idec MA Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of PLEGRIDY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for PLEGRIDY is 2,643 days. Of this time, 2,186 days occurred during the testing phase of the regulatory review period, while 457 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 23, 2007. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on May 23, 2007. VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): May 16, 2013. FDA has verified the applicant’s claim that the biologics license application (BLA) for PLEGRIDY (BLA 125499) was initially submitted on May 16, 2013. 3. The date the application was approved: August 15, 2014. FDA has verified the applicant’s claim that BLA 125499 was approved on August 15, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,284 days, 762 days, or 346 days of patent term extension, respectively. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25222 Filed 10–18–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 72063 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: Notice. 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 requirements for premarket approval of medical devices. DATES: Submit either electronic or written comments on the collection of information by December 19, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://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’’). E:\FR\FM\19OCN1.SGM 19OCN1 72064 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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–0825 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://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 http:// 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. VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// 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 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. 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 Approval of Medical Devices—21 CFR part 814—OMB Control Number 0910–0231—Extension Under section 515 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e) all devices PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 placed into class III by FDA are subject to premarket approval requirements. Premarket approval (PMA) is the process of scientific and regulatory review to ensure the safety and effectiveness of class III devices. An approved PMA is, in effect, a private license granted to the applicant for marketing a particular medical device. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act 21 U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements apply differently to preamendments devices, postamendments devices, and transitional class III devices. Manufacturers of class III preamendments devices, devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until 30 months after the issuance of a final classification regulation or until 90 days after the publication of a final regulation requiring the submission of a PMA, whichever period is later. FDA may allow more than 90 days after issuance of a final rule for submission of a PMA. A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices determined by FDA to be substantially equivalent to preamendments class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant’s premarket notification submitted in accordance with section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into class I or II are ‘‘new’’ devices and fall automatically into class III. Before such devices can be marketed, they must have an approved premarket approval application or be must reclassified into class I or class II. The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105–115) was enacted on November 21, 1997, to implement revisions to the FD&C Act by streamlining the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act, which provided that PMA supplements were required for all device changes that affect safety and effectiveness unless such changes are modifications to manufacturing procedures or method of manufacture. That type of manufacturing change will require a 30-day notice, or where FDA E:\FR\FM\19OCN1.SGM 19OCN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices finds such notice inadequate, a 135-day PMA supplement. The implementing regulations, contained in part 814 (21 CFR part 814), further specify the contents of a PMA for a medical device and the criteria FDA will employ in approving, denying, or withdrawing approval of a PMA and supplements to PMAs. The regulations’ purpose is to establish an efficient and thorough procedure for FDA’s review of PMAs and supplements to PMAs for class III medical devices. The regulations facilitate the approval of PMAs and supplements to PMAs for devices that have been shown to be reasonably safe and effective and otherwise meet the statutory criteria for approval. The regulations also ensure the denial of PMAs and supplements to PMAs for devices that have not been shown to be reasonably safe and effective and that do not otherwise meet the statutory criteria for approval. The industry-wide burden estimate for PMAs is based on an FDA average fiscal year (FY) annual rate of receipt of PMA submissions data FY 2013 through 2015 and our expectation of submissions to come in the next few years. The burden data for PMAs is based on data provided by applicants by device type and cost element in an earlier study. Reporting Burden: The reporting burden can be broken out by certain sections of the PMA regulations and the FD&C Act as follows: § 814.15(b)—Research Conducted Outside the United States. Each foreign study should be performed in accordance with the ‘‘Declaration of Helsinki’’ or the laws and regulations of the country in which the study was conducted. If the study was conducted in accordance with the laws of the country, the PMA applicant is required to explain to FDA in detail the differences between the laws of the country and the ‘‘Declaration of Helsinki.’’ Based on the number of PMAs received that contained studies from overseas, FDA estimates that the burden estimate necessary to meet this requirement is 50 hours. § 814.20—Application. Included in this requirement are the conduct of laboratory and clinical trials as well as the analysis, review, and physical preparation of the PMA application. FDA estimates that 35 applicants, including hospital re-manufacturers of single-use devices, will be affected by these requirements which are based on the actual average of FDA receipt of new PMA applications in FY 2013 through 2015. FDA’s estimate of the hours per response (668) was derived through FDA’s experience and consultation with VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 industry and trade associations. In addition, FDA also based its estimate on the results of an earlier study that accounts for the bulk of the hourly burden for this requirement, which is identified by applicants. § 814.37(a) through (c) and (e)—PMA Amendments and Resubmitted PMAs. As part of the review process, FDA often requests the PMA applicant to submit additional information regarding the device necessary for FDA to file the PMA or to complete its review and make a final decision. The PMA applicant may, also on their own initiative, submit additional information to FDA during the review process. These amendments contain information ranging from additional test results, reanalysis of the original data set, to revised device labeling. Almost all PMAs received by the Agency have amendments submitted during the review process. § 814.39(a)—PMA Supplements. This information collection includes the requirements for the range of PMA supplements (panel track, 180-day feebased, 180-day non-fee based, and realtime supplements). § 814.39(d)—Special PMA Supplements—Changes Being Affected. This type of supplement is intended to enhance the safety of the device or the safe use of the device. The number of PMA supplements received that fit this category averaged 88 per year based on the numbers received from FY 2013 through FY 2015. Because of the minimal data required to be included in this type of supplement, FDA estimates that the burden hours necessary to satisfy this requirement are 528 hours. § 814.39(f)—30-Day Notice. Under section 515(d) of the FD&C Act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement under paragraph (a) of this section and are eligible to be the subject of a 30-day notice. A 30-day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of part 820 (21 CFR part 820). The applicant may distribute the device 30 days after the date on which FDA receives the 30-day notice, unless FDA notifies the applicant within 30 days from receipt of the notice, that it is not adequate. § 814.82(a)(9)—Postapproval Requirements. Postapproval requirements concerns approved PMAs that were not reclassified and require a periodic report. After approval, all PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 72065 PMAs require a submission of an annual report. A majority of the submitted PMAs require associated postapproval studies, i.e., followup of patients used in clinical trials to support the PMA or additional preclinical information that is labor-intensive to compile and complete; the remaining PMAs require minimal information. § 814.84(b)—Periodic Reports. Postapproval requirements described in § 814.82(a)(7) require submission of an annual report for each approved PMA. FDA estimates that respondents will average about 10 hours in preparing their reports to meet this requirement. This estimate is based on FDA’s experience and consultation with industry. Expedited or Priority Review—Section 515(d)(5) of the FD&C Act. FDA will provide special review, which can include expedited processing of a PMA application, for certain devices intended to treat or diagnose life threatening or irreversibly debilitating diseases or conditions. To receive special review, the devices must meet one of the following criteria: • The device represents a breakthrough technology; • There are no approved alternatives; • The use of the device offers significant advantages over existing approved alternatives; • Availability is in the best interest of the patients. Agreement Meeting—Section 520(g)(7) of the FD&C Act (21 U.S.C. 360j(g)(7)). Applicants planning to submit a PMA may submit a written request to reach agreement with FDA on the key parameters of the investigational plan. Determination Meeting—Section 513(a)(3)(D) of the FD&C Act (21 U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a written request to FDA for a meeting to determine the type of information (valid scientific evidence) necessary to support the effectiveness of their device. Panel of Experts—Section 515(c)(3) of the FD&C Act. An original PMA or panel track PMA supplement is taken to an advisory panel of experts unless FDA determines that the information in the application substantially duplicates information which has previously been reviewed by the panel. Day 100 Meeting—Section 515(d)(3) of the FD&C Act. FDA must, upon the written request of the applicant, meet with that party within 100 days of receipt of the filed PMA application to discuss the review status of the application. With the concurrence of the applicant, a different schedule may be established. Prior to this meeting, FDA must inform the applicant in writing of E:\FR\FM\19OCN1.SGM 19OCN1 72066 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices any identified deficiencies and what information is required to correct those deficiencies. FDA must also promptly notify the applicant if FDA identifies additional deficiencies or of any additional information required to complete Agency review. Recordkeeping § 814.82(a)(5) and (a)(6)— Maintenance of Records. The recordkeeping burden under this section requires the maintenance of records, used to trace patients and the organization and indexing of records into identifiable files to ensure the device’s continued safety and effectiveness. These records are required of all applicants who have an approved PMA. PMAs have been required since 1976, and there are 725 active PMAs that could be subject to these requirements, based on actual FDA data, and approximately 30 new PMAs are approved every year. The aggregate burden for the estimated 422 PMA holders of approved original PMAs for the next few years is estimated to be 7,174 hours. The applicant determines which records should be maintained during product development to document and/ or substantiate the device’s safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (21 CFR part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device’s continuing safety and effectiveness. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR or FD&C Act section Research conducted outside the United States (814.15(b)) PMA application (814.20) .................................................... PMA amendments and resubmitted PMAs (814.37(a)–(c) and (e)) ............................................................................. PMA supplements (814.39(a)) ............................................. Special PMA supplement—changes being affected (814.39(d)) ........................................................................ 30-day notice (814.39(f)) ..................................................... Postapproval requirements (814.82(a)(9)) ........................... Periodic reports (814.84(b)) ................................................. Agreement meeting (520(g)(7)) ........................................... Expedited review request (515(d)(5) of the FD&C Act) ...... Determination Meeting (513(1)(3)(D) of the FD&C Act) ...... Panel meeting (515(c)(3) of the FD&C Act) ........................ Day 100 meeting (515(d)(3) of the FD&C Act) ................... Total .............................................................................. 1 There Number of responses per respondent Total annual responses Average burden per response Total hours 25 35 1 1 25 35 2 668 50 23,380 1,222 695 1 1 1,222 695 167 60 204,074 41,700 88 1,710 340 695 1 6 1 9 19 1 1 1 1 1 1 1 1 1 88 1,710 340 695 1 6 1 9 19 6 16 135 10 50 10 50 30 10 528 27,360 45,900 6,950 50 60 50 270 190 ........................ ........................ ........................ ........................ 350,562 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity/21 CFR section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Maintenance of records (814.82(a)(5) and (a)(6)) ............... 422 1 422 17 7,174 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 13, 2016. Leslie Kux, Associate Commissioner for Policy. ACTION: Authority: 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended. The Committee is governed by the provisions of Public Law 92–463, as amended (5 U.S.C. App. 2), which sets forth standards for the formation and use of advisory committees. [FR Doc. 2016–25232 Filed 10–18–16; 8:45 am] BILLING CODE 4164–01–P sradovich on DSK3GMQ082PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant SUMMARY: Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee AGENCY: Notice. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of two Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated. DATES: Applications for individuals to be considered for appointment to the Committee must be received no later than 5 p.m. EDT on November 18, 2016 at the address listed below. ADDRESSES: All nominations should be mailed or delivered to Commander, (CDR) Gustavo Seinos, MPH, Designated E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72063-72066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25232]


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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: Notice.

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

SUMMARY: 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 requirements for premarket 
approval of medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by December 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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'').

[[Page 72064]]

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-0825 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Premarket Approval of Medical 
Devices'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://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 http://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 http://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 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

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 Approval of Medical Devices--21 CFR part 814--OMB Control 
Number 0910-0231--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are 
subject to premarket approval requirements. Premarket approval (PMA) is 
the process of scientific and regulatory review to ensure the safety 
and effectiveness of class III devices. An approved PMA is, in effect, 
a private license granted to the applicant for marketing a particular 
medical device. A class III device that fails to meet PMA requirements 
is considered to be adulterated under section 501(f) of the FD&C Act 21 
U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements 
apply differently to preamendments devices, postamendments devices, and 
transitional class III devices.
    Manufacturers of class III preamendments devices, devices that were 
in commercial distribution before May 28, 1976, are not required to 
submit a PMA until 30 months after the issuance of a final 
classification regulation or until 90 days after the publication of a 
final regulation requiring the submission of a PMA, whichever period is 
later. FDA may allow more than 90 days after issuance of a final rule 
for submission of a PMA.
    A postamendments device is one that was first distributed 
commercially on or after May 28, 1976. Postamendments devices 
determined by FDA to be substantially equivalent to preamendments class 
III devices are subject to the same requirements as the preamendments 
devices. FDA determines substantial equivalence after reviewing an 
applicant's premarket notification submitted in accordance with section 
510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices 
determined by FDA to be not substantially equivalent to either 
preamendments devices or postamendments devices classified into class I 
or II are ``new'' devices and fall automatically into class III. Before 
such devices can be marketed, they must have an approved premarket 
approval application or be must reclassified into class I or class II.
    The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115) was enacted on November 21, 1997, to implement revisions to the 
FD&C Act by streamlining the process of bringing safe and effective 
drugs, medical devices, and other therapies to the U.S. market. FDAMA 
added section 515(d)(6) to the FD&C Act, which provided that PMA 
supplements were required for all device changes that affect safety and 
effectiveness unless such changes are modifications to manufacturing 
procedures or method of manufacture. That type of manufacturing change 
will require a 30-day notice, or where FDA

[[Page 72065]]

finds such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in part 814 (21 CFR part 
814), further specify the contents of a PMA for a medical device and 
the criteria FDA will employ in approving, denying, or withdrawing 
approval of a PMA and supplements to PMAs. The regulations' purpose is 
to establish an efficient and thorough procedure for FDA's review of 
PMAs and supplements to PMAs for class III medical devices. The 
regulations facilitate the approval of PMAs and supplements to PMAs for 
devices that have been shown to be reasonably safe and effective and 
otherwise meet the statutory criteria for approval. The regulations 
also ensure the denial of PMAs and supplements to PMAs for devices that 
have not been shown to be reasonably safe and effective and that do not 
otherwise meet the statutory criteria for approval.
    The industry-wide burden estimate for PMAs is based on an FDA 
average fiscal year (FY) annual rate of receipt of PMA submissions data 
FY 2013 through 2015 and our expectation of submissions to come in the 
next few years. The burden data for PMAs is based on data provided by 
applicants by device type and cost element in an earlier study.
    Reporting Burden: The reporting burden can be broken out by certain 
sections of the PMA regulations and the FD&C Act as follows:
    Sec.  814.15(b)--Research Conducted Outside the United States. Each 
foreign study should be performed in accordance with the ``Declaration 
of Helsinki'' or the laws and regulations of the country in which the 
study was conducted. If the study was conducted in accordance with the 
laws of the country, the PMA applicant is required to explain to FDA in 
detail the differences between the laws of the country and the 
``Declaration of Helsinki.'' Based on the number of PMAs received that 
contained studies from overseas, FDA estimates that the burden estimate 
necessary to meet this requirement is 50 hours.
    Sec.  814.20--Application. Included in this requirement are the 
conduct of laboratory and clinical trials as well as the analysis, 
review, and physical preparation of the PMA application. FDA estimates 
that 35 applicants, including hospital re-manufacturers of single-use 
devices, will be affected by these requirements which are based on the 
actual average of FDA receipt of new PMA applications in FY 2013 
through 2015. FDA's estimate of the hours per response (668) was 
derived through FDA's experience and consultation with industry and 
trade associations. In addition, FDA also based its estimate on the 
results of an earlier study that accounts for the bulk of the hourly 
burden for this requirement, which is identified by applicants.
    Sec.  814.37(a) through (c) and (e)--PMA Amendments and Resubmitted 
PMAs. As part of the review process, FDA often requests the PMA 
applicant to submit additional information regarding the device 
necessary for FDA to file the PMA or to complete its review and make a 
final decision. The PMA applicant may, also on their own initiative, 
submit additional information to FDA during the review process. These 
amendments contain information ranging from additional test results, 
re-analysis of the original data set, to revised device labeling. 
Almost all PMAs received by the Agency have amendments submitted during 
the review process.
    Sec.  814.39(a)--PMA Supplements. This information collection 
includes the requirements for the range of PMA supplements (panel 
track, 180-day fee-based, 180-day non-fee based, and real-time 
supplements).
    Sec.  814.39(d)--Special PMA Supplements--Changes Being Affected. 
This type of supplement is intended to enhance the safety of the device 
or the safe use of the device. The number of PMA supplements received 
that fit this category averaged 88 per year based on the numbers 
received from FY 2013 through FY 2015. Because of the minimal data 
required to be included in this type of supplement, FDA estimates that 
the burden hours necessary to satisfy this requirement are 528 hours.
    Sec.  814.39(f)--30-Day Notice. Under section 515(d) of the FD&C 
Act, modifications to manufacturing procedures or methods of 
manufacture that affect the safety and effectiveness of a device 
subject to an approved PMA do not require submission of a PMA 
supplement under paragraph (a) of this section and are eligible to be 
the subject of a 30-day notice. A 30-day notice shall describe in 
detail the change, summarize the data or information supporting the 
change, and state that the change has been made in accordance with the 
requirements of part 820 (21 CFR part 820). The applicant may 
distribute the device 30 days after the date on which FDA receives the 
30-day notice, unless FDA notifies the applicant within 30 days from 
receipt of the notice, that it is not adequate.
    Sec.  814.82(a)(9)--Postapproval Requirements. Postapproval 
requirements concerns approved PMAs that were not reclassified and 
require a periodic report. After approval, all PMAs require a 
submission of an annual report. A majority of the submitted PMAs 
require associated postapproval studies, i.e., followup of patients 
used in clinical trials to support the PMA or additional preclinical 
information that is labor-intensive to compile and complete; the 
remaining PMAs require minimal information.
    Sec.  814.84(b)--Periodic Reports. Postapproval requirements 
described in Sec.  814.82(a)(7) require submission of an annual report 
for each approved PMA. FDA estimates that respondents will average 
about 10 hours in preparing their reports to meet this requirement. 
This estimate is based on FDA's experience and consultation with 
industry.
    Expedited or Priority Review--Section 515(d)(5) of the FD&C Act. 
FDA will provide special review, which can include expedited processing 
of a PMA application, for certain devices intended to treat or diagnose 
life threatening or irreversibly debilitating diseases or conditions. 
To receive special review, the devices must meet one of the following 
criteria:
     The device represents a breakthrough technology;
     There are no approved alternatives;
     The use of the device offers significant advantages over 
existing approved alternatives;
     Availability is in the best interest of the patients.
    Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C. 
360j(g)(7)). Applicants planning to submit a PMA may submit a written 
request to reach agreement with FDA on the key parameters of the 
investigational plan.
    Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21 
U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a 
written request to FDA for a meeting to determine the type of 
information (valid scientific evidence) necessary to support the 
effectiveness of their device.
    Panel of Experts--Section 515(c)(3) of the FD&C Act. An original 
PMA or panel track PMA supplement is taken to an advisory panel of 
experts unless FDA determines that the information in the application 
substantially duplicates information which has previously been reviewed 
by the panel.
    Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon 
the written request of the applicant, meet with that party within 100 
days of receipt of the filed PMA application to discuss the review 
status of the application. With the concurrence of the applicant, a 
different schedule may be established. Prior to this meeting, FDA must 
inform the applicant in writing of

[[Page 72066]]

any identified deficiencies and what information is required to correct 
those deficiencies. FDA must also promptly notify the applicant if FDA 
identifies additional deficiencies or of any additional information 
required to complete Agency review.

Recordkeeping

    Sec.  814.82(a)(5) and (a)(6)--Maintenance of Records. The 
recordkeeping burden under this section requires the maintenance of 
records, used to trace patients and the organization and indexing of 
records into identifiable files to ensure the device's continued safety 
and effectiveness. These records are required of all applicants who 
have an approved PMA.
    PMAs have been required since 1976, and there are 725 active PMAs 
that could be subject to these requirements, based on actual FDA data, 
and approximately 30 new PMAs are approved every year. The aggregate 
burden for the estimated 422 PMA holders of approved original PMAs for 
the next few years is estimated to be 7,174 hours.
    The applicant determines which records should be maintained during 
product development to document and/or substantiate the device's safety 
and effectiveness. Records required by the current good manufacturing 
practices for medical devices regulation (21 CFR part 820) may be 
relevant to a PMA review and may be submitted as part of an 
application. In individual instances, records may be required as 
conditions of approval to ensure the device's continuing safety and 
effectiveness.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   Activity/21 CFR or FD&C Act       Number of    responses  per   Total annual   Average burden    Total hours
             section                respondents      respondent      responses     per response
----------------------------------------------------------------------------------------------------------------
Research conducted outside the                25               1              25               2              50
 United States (814.15(b))......
PMA application (814.20)........              35               1              35             668          23,380
PMA amendments and resubmitted             1,222               1           1,222             167         204,074
 PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a)).....             695               1             695              60          41,700
Special PMA supplement--changes               88               1              88               6             528
 being affected (814.39(d)).....
30-day notice (814.39(f)).......           1,710               1           1,710              16          27,360
Postapproval requirements                    340               1             340             135          45,900
 (814.82(a)(9)).................
Periodic reports (814.84(b))....             695               1             695              10           6,950
Agreement meeting (520(g)(7))...               1               1               1              50              50
Expedited review request                       6               1               6              10              60
 (515(d)(5) of the FD&C Act)....
Determination Meeting                          1               1               1              50              50
 (513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the                9               1               9              30             270
 FD&C Act)......................
Day 100 meeting (515(d)(3) of                 19               1              19              10             190
 the FD&C Act)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         350,562
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records  per     Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))...................             422                1              422               17            7,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25232 Filed 10-18-16; 8:45 am]
 BILLING CODE 4164-01-P