Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records, 12735-12737 [2016-05385]

Download as PDF Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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. Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information OMB Control Number 0910–0754—Extension This final Guidance for Industry and FDA staff entitled ‘‘Dear Health Care Provider Letters: Improving Communication of Important Safety Information’’ offers specific guidance to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance gives specific instruction on what should and should not be included in DHCP letters. To date, some DHCP letters have been too long, have contained promotional 12735 material, or otherwise have not met the goals set forth in the applicable regulation (21 CFR 200.5). In some cases, health care providers have not been aware of important new information, and have been unable to communicate it to patients, because the letters’ content and length have made it difficult to find the relevant information. In addition, letters have sometimes been sent for the wrong reasons. In addition to content and format recommendations for each type of DHCP letter, the guidance also includes advice on consulting with FDA to develop a DHCP letter, when to send a letter, what type of letter to send, and conducting an assessment of the letter’s impact. Based on a review of FDA’s Document Archiving, Reporting, and Regulatory Tracking System for 2012–2015, we identified DHCP letters that were sent and the identity of each sponsor sending out a DHCP letter for each year. We estimate that we will receive approximately 25 DHCP Letters annually from approximately 18 application holders. FDA professionals familiar with DHCP letters and with the recommendations in the guidance estimate that it should take an application holder approximately 100 hours to prepare and send DHCP letters in accordance with the guidance. FDA estimates the annual reporting burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Annual Average .................................................... 1 There 18 Total annual responses 1.4 25 Average burden per response 100 hours ..................... Total hours 2,500 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05301 Filed 3–9–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0477] BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES Number of responses per respondent Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing SUMMARY: VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Fax written comments on the collection of information by April 11, 2016. DATES: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records AGENCY: 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. 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 0910–0078. Also ADDRESSES: E:\FR\FM\10MRN1.SGM 10MRN1 12736 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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. Investigational Device Exemptions Reports and Records— OMB Control Number 0910–0078—Extension Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect information regarding investigational devices, and establishes rules under which new medical devices may be tested using human subjects in a clinical setting. The Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) added section 520(g)(6) to the FD&C Act and permitted changes to be made to either the investigational device or to the clinical protocol without FDA approval of an investigational device exemption (IDE) supplement. An IDE allows a device, which would otherwise be subject to provisions of the FD&C Act, such as premarket notification or premarket approval, to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. The purpose of part 812 (21 CFR part 812) is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use. The IDE regulation is designed to encourage the development of useful medical devices and allow investigators the maximum freedom possible, without jeopardizing the health and safety of the public or violating ethical standards. To do this, the regulation provides for different levels of regulatory control, depending on the level of potential risk the investigational device presents to human subjects. Investigations of significant risk devices, ones that present a potential for VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 serious harm to the rights, safety, or welfare of human subjects, are subject to the full requirements of the IDE regulation. Nonsignificant risk device investigations, i.e., devices that do not present a potential for serious harm, are subject to the reduced burden of the abbreviated requirements. The regulation also includes provisions for treatment IDEs. The purpose of these provisions is to facilitate the availability, as early in the device development process as possible, of promising new devices to patients with life-threatening or serious conditions for which no comparable or satisfactory alternative therapy is available. Section 812.10 permits the sponsor of the IDE to request a waiver to all of the requirements of part 812. This information is needed for FDA to determine if waiver of the requirements of part 812 will impact the public’s health and safety. Sections 812.20, 812.25, and 812.27 consist of the information necessary to file an IDE application with FDA. The submission of an IDE application to FDA is required only for significant risk device investigations. Section 812.20 lists the data requirements for the original IDE application, § 812.25 lists the contents of the investigational plan; and § 812.27 lists the data relating to previous investigations or testing. The information in the original IDE application is evaluated by the Center for Devices and Radiological Health to determine whether the proposed investigation will reasonably protect the public health and safety, and for FDA to make a determination to approve the IDE. Upon approval of an IDE application by FDA, a sponsor must submit certain requests and reports. Under § 812.35, a sponsor who wishes to make a change in the investigation that affects the scientific soundness of the study or the rights, safety, or welfare of the subjects, is required to submit a request for the change to FDA. Section 812.150 requires a sponsor to submit reports to FDA. These requests and reports are submitted to FDA as supplemental applications. This information is needed for FDA to assure protection of human subjects and to allow review of the study’s progress. Section 812.36(c) identifies the information necessary to PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 file a treatment IDE application. FDA uses this information to determine if wider distribution of the device is in the interest of the public health. Section 812.36(f) identifies the reports required to allow FDA to monitor the size and scope of the treatment IDE, to assess the sponsor’s due diligence in obtaining marketing clearance of the device, and to ensure the integrity of the controlled clinical trials. Section 812.140 lists the recordkeeping requirements for investigators and sponsors. FDA requires this information for tracking and oversight purposes. Investigators are required to maintain records, including correspondence and reports concerning the study, records of receipt, use or disposition of devices, records of each subject’s case history and exposure to the device, informed consent documentation, study protocol, and documentation of any deviation from the protocol. Sponsors are required to maintain records including correspondence and reports concerning the study, records of shipment and disposition, signed investigator agreements, adverse device effects information, and, for a nonsignificant risk device study, an explanation of the nonsignificant risk determination, records of device name and intended use, study objectives, investigator information, investigational review board information, and statement on the extent that good manufacturing practices will be followed. For a nonsignificant risk device investigation, the investigators’ and sponsors’ recordkeeping and reporting burden is reduced. Pertinent records on the study must be maintained by both parties, and reports are made to sponsors and institutional review boards (IRBs). Reports are made to FDA only in certain circumstances, e.g., recall of the device, the occurrence of unanticipated adverse effects, and as a consequence of certain IRB actions. The estimate of the burden is based on the number of IDEs received in recent years. In the Federal Register of October 28, 2015 (80 FR 66009), 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\10MRN1.SGM 10MRN1 12737 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Waivers—812.10 .................................................................. IDE Application—812.20, 812.25, and 812.27 .................... Supplements—812.35 and 812.150 .................................... Treatment IDE Applications—812.36(c) .............................. Treatment IDE Reporting—812.36(f) ................................... 1 219 579 1 1 1 1 6 1 1 1 219 3,474 1 1 1 80 6 120 20 1 17,520 20,844 120 20 Total .............................................................................. ........................ ........................ ........................ ........................ 38,505 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 recordkeepers Activity/21 CFR section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Original—812.140 .............................................................. Supplemental—812.140 ..................................................... Nonsignificant—812.140 .................................................... 219 579 356 1 6 1 219 3,747 356 10 1 6 2,190 3,474 2,136 Total ............................................................................ ........................ .......................... ........................ ........................ 7,800 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity/21 CFR section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Reports for Nonsignificant Risk Studies—812.150 ........... 1 1 1 6 6 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual reporting burden for this extension has decreased to 38,505 hours (previously 54,253 hours) as the result of a decrease in the average number of applications and supplements submitted. For the same reason, the recordkeeping burden has decreased to 7,800 hours (previously 9,968). The previous approved total burden hours of 64,227, have therefore decreased by 17,916 to 46,311. Dated: March 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05385 Filed 3–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2015–N–0986] Center for Devices and Radiological Health: Experiential Learning Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2016 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the ELP. DATES: Submit either an electronic or written request for participation in the ELP by April 11, 2016. ADDRESSES: Submit either electronic requests to http://www.regulations.gov or written requests to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify requests with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993–0002, 240–402–2246, FAX: 301–827–3079, Christian.Hussong@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background CDRH is responsible for helping to ensure the safety and effectiveness of medical devices marketed in the United States. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices. In support of this mission, the Center launched various training and development initiatives to enhance performance of its staff involved in regulatory review and in the premarket review process. One of these initiatives, the ELP Pilot, was launched in 2012 and fully implemented on April 2, 2013 (78 FR 19711). CDRH is committed to advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and helping to ensure consumer confidence in medical devices marketed in the United States E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12735-12737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05385]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0477]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Investigational 
Device Exemptions Reports and Records

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 
11, 2016.

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 0910-0078. 
Also

[[Page 12736]]

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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

Investigational Device Exemptions Reports and Records-- OMB Control 
Number 0910-0078--Extension

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360j(g)) establishes the statutory authority to 
collect information regarding investigational devices, and establishes 
rules under which new medical devices may be tested using human 
subjects in a clinical setting. The Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115) added section 520(g)(6) to 
the FD&C Act and permitted changes to be made to either the 
investigational device or to the clinical protocol without FDA approval 
of an investigational device exemption (IDE) supplement. An IDE allows 
a device, which would otherwise be subject to provisions of the FD&C 
Act, such as premarket notification or premarket approval, to be used 
in investigations involving human subjects in which the safety and 
effectiveness of the device is being studied. The purpose of part 812 
(21 CFR part 812) is to encourage, to the extent consistent with the 
protection of public health and safety and with ethical standards, the 
discovery and development of useful devices intended for human use. The 
IDE regulation is designed to encourage the development of useful 
medical devices and allow investigators the maximum freedom possible, 
without jeopardizing the health and safety of the public or violating 
ethical standards. To do this, the regulation provides for different 
levels of regulatory control, depending on the level of potential risk 
the investigational device presents to human subjects.
    Investigations of significant risk devices, ones that present a 
potential for serious harm to the rights, safety, or welfare of human 
subjects, are subject to the full requirements of the IDE regulation. 
Nonsignificant risk device investigations, i.e., devices that do not 
present a potential for serious harm, are subject to the reduced burden 
of the abbreviated requirements. The regulation also includes 
provisions for treatment IDEs. The purpose of these provisions is to 
facilitate the availability, as early in the device development process 
as possible, of promising new devices to patients with life-threatening 
or serious conditions for which no comparable or satisfactory 
alternative therapy is available. Section 812.10 permits the sponsor of 
the IDE to request a waiver to all of the requirements of part 812. 
This information is needed for FDA to determine if waiver of the 
requirements of part 812 will impact the public's health and safety. 
Sections 812.20, 812.25, and 812.27 consist of the information 
necessary to file an IDE application with FDA. The submission of an IDE 
application to FDA is required only for significant risk device 
investigations.
    Section 812.20 lists the data requirements for the original IDE 
application, Sec.  812.25 lists the contents of the investigational 
plan; and Sec.  812.27 lists the data relating to previous 
investigations or testing. The information in the original IDE 
application is evaluated by the Center for Devices and Radiological 
Health to determine whether the proposed investigation will reasonably 
protect the public health and safety, and for FDA to make a 
determination to approve the IDE.
    Upon approval of an IDE application by FDA, a sponsor must submit 
certain requests and reports. Under Sec.  812.35, a sponsor who wishes 
to make a change in the investigation that affects the scientific 
soundness of the study or the rights, safety, or welfare of the 
subjects, is required to submit a request for the change to FDA. 
Section 812.150 requires a sponsor to submit reports to FDA. These 
requests and reports are submitted to FDA as supplemental applications. 
This information is needed for FDA to assure protection of human 
subjects and to allow review of the study's progress. Section 812.36(c) 
identifies the information necessary to file a treatment IDE 
application. FDA uses this information to determine if wider 
distribution of the device is in the interest of the public health. 
Section 812.36(f) identifies the reports required to allow FDA to 
monitor the size and scope of the treatment IDE, to assess the 
sponsor's due diligence in obtaining marketing clearance of the device, 
and to ensure the integrity of the controlled clinical trials.
    Section 812.140 lists the recordkeeping requirements for 
investigators and sponsors. FDA requires this information for tracking 
and oversight purposes. Investigators are required to maintain records, 
including correspondence and reports concerning the study, records of 
receipt, use or disposition of devices, records of each subject's case 
history and exposure to the device, informed consent documentation, 
study protocol, and documentation of any deviation from the protocol. 
Sponsors are required to maintain records including correspondence and 
reports concerning the study, records of shipment and disposition, 
signed investigator agreements, adverse device effects information, 
and, for a nonsignificant risk device study, an explanation of the 
nonsignificant risk determination, records of device name and intended 
use, study objectives, investigator information, investigational review 
board information, and statement on the extent that good manufacturing 
practices will be followed.
    For a nonsignificant risk device investigation, the investigators' 
and sponsors' recordkeeping and reporting burden is reduced. Pertinent 
records on the study must be maintained by both parties, and reports 
are made to sponsors and institutional review boards (IRBs). Reports 
are made to FDA only in certain circumstances, e.g., recall of the 
device, the occurrence of unanticipated adverse effects, and as a 
consequence of certain IRB actions. The estimate of the burden is based 
on the number of IDEs received in recent years.
    In the Federal Register of October 28, 2015 (80 FR 66009), 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:

[[Page 12737]]



                                 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
----------------------------------------------------------------------------------------------------------------
Waivers--812.10.................               1               1               1               1               1
IDE Application--812.20, 812.25,             219               1             219              80          17,520
 and 812.27.....................
Supplements--812.35 and 812.150.             579               6           3,474               6          20,844
Treatment IDE Applications--                   1               1               1             120             120
 812.36(c)......................
Treatment IDE Reporting--                      1               1               1              20              20
 812.36(f)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          38,505
----------------------------------------------------------------------------------------------------------------
\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
    Activity/21 CFR section         Number of      records per     Total annual     burden per      Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Original--812.140..............             219                1             219              10           2,190
Supplemental--812.140..........             579                6           3,747               1           3,474
Nonsignificant--812.140........             356                1             356               6           2,136
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............           7,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                          Number of      disclosures per    Total annual   Average  burden    Total hours
                                                                      respondents       respondent       disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk Studies--812.150..................               1                 1                1                6                6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated annual reporting burden for this extension has 
decreased to 38,505 hours (previously 54,253 hours) as the result of a 
decrease in the average number of applications and supplements 
submitted. For the same reason, the recordkeeping burden has decreased 
to 7,800 hours (previously 9,968). The previous approved total burden 
hours of 64,227, have therefore decreased by 17,916 to 46,311.

    Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05385 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P