81 FR 12735 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 47 (March 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 47 (March 10, 2016)
| Page Range | 12735-12737 | |
| FR Document | 2016-05385 |
[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)] [Notices] [Pages 12735-12737] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [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. 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
![Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12735
Management, 5630 Fishers Lane, Rm. utility; (2) the accuracy of FDA’s material, or otherwise have not met the
1061, Rockville, MD 20852. estimate of the burden of the proposed goals set forth in the applicable
FOR FURTHER INFORMATION CONTACT: FDA collection of information, including the regulation (21 CFR 200.5). In some
PRA Staff, Office of Operations, Food validity of the methodology and cases, health care providers have not
and Drug Administration, 8455 assumptions used; (3) ways to enhance been aware of important new
Colesville Rd., COLE–14526, Silver the quality, utility, and clarity of the information, and have been unable to
Spring, MD 20993–0002, PRAStaff@ information to be collected; and (4) communicate it to patients, because the
fda.hhs.gov. ways to minimize the burden of the letters’ content and length have made it
SUPPLEMENTARY INFORMATION: Under the
collection of information on difficult to find the relevant
PRA (44 U.S.C. 3501–3520), Federal respondents, including through the use information. In addition, letters have
Agencies must obtain approval from the of automated collection techniques, sometimes been sent for the wrong
Office of Management and Budget when appropriate, and other forms of reasons.
(OMB) for each collection of information technology. In addition to content and format
information they conduct or sponsor. Guidance for Industry and Food and recommendations for each type of DHCP
‘‘Collection of information’’ is defined Drug Administration Staff on Dear letter, the guidance also includes advice
in 44 U.S.C. 3502(3) and 5 CFR Health Care Provider Letters: on consulting with FDA to develop a
1320.3(c) and includes Agency requests Improving Communication of DHCP letter, when to send a letter, what
or requirements that members of the Important Safety Information OMB type of letter to send, and conducting an
public submit reports, keep records, or Control Number 0910–0754—Extension assessment of the letter’s impact.
provide information to a third party.
This final Guidance for Industry and Based on a review of FDA’s Document
Section 3506(c)(2)(A) of the PRA (44
FDA staff entitled ‘‘Dear Health Care Archiving, Reporting, and Regulatory
U.S.C. 3506(c)(2)(A)) requires Federal
Provider Letters: Improving Tracking System for 2012–2015, we
Agencies to provide a 60-day notice in
Communication of Important Safety identified DHCP letters that were sent
the Federal Register concerning each
Information’’ offers specific guidance to and the identity of each sponsor sending
proposed collection of information,
industry and FDA staff on the content out a DHCP letter for each year. We
including each proposed extension of an
and format of Dear Health Care Provider estimate that we will receive
existing collection of information,
(DHCP) letters. These letters are sent by approximately 25 DHCP Letters
before submitting the collection to OMB
for approval. To comply with this manufacturers or distributors to health annually from approximately 18
requirement, FDA is publishing notice care providers to communicate an application holders. FDA professionals
of the proposed collection of important drug warning, a change in familiar with DHCP letters and with the
information set forth in this document. prescribing information, or a correction recommendations in the guidance
With respect to the following of misinformation in prescription drug estimate that it should take an
collection of information, FDA invites promotional labeling or advertising. application holder approximately 100
comments on these topics: (1) Whether This guidance gives specific hours to prepare and send DHCP letters
the proposed collection of information instruction on what should and should in accordance with the guidance.
is necessary for the proper performance not be included in DHCP letters. To FDA estimates the annual reporting
of FDA’s functions, including whether date, some DHCP letters have been too burden of this collection of information
the information will have practical long, have contained promotional as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
Annual Average .................................................... 18 1.4 25 100 hours ..................... 2,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 3, 2016. DEPARTMENT OF HEALTH AND that a proposed collection of
Leslie Kux, HUMAN SERVICES information has been submitted to the
Associate Commissioner for Policy. Office of Management and Budget
Food and Drug Administration (OMB) for review and clearance under
[FR Doc. 2016–05301 Filed 3–9–16; 8:45 am]
the Paperwork Reduction Act of 1995.
BILLING CODE 4164–01–P [Docket No. FDA–2012–N–0477]
DATES: Fax written comments on the
Agency Information Collection collection of information by April 11,
Activities; Submission for Office of 2016.
Management and Budget Review;
ADDRESSES: To ensure that comments on
Comment Request; Investigational
the information collection are received,
Device Exemptions Reports and
mstockstill on DSK4VPTVN1PROD with NOTICES
OMB recommends that written
Records
comments be faxed to the Office of
AGENCY: Food and Drug Administration, Information and Regulatory Affairs,
HHS. OMB, Attn: FDA Desk Officer, FAX:
ACTION: Notice. 202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
SUMMARY: The Food and Drug comments should be identified with the
Administration (FDA) is announcing OMB control number 0910–0078. Also
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![Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12737
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Waivers—812.10 .................................................................. 1 1 1 1 1
IDE Application—812.20, 812.25, and 812.27 .................... 219 1 219 80 17,520
Supplements—812.35 and 812.150 .................................... 579 6 3,474 6 20,844
Treatment IDE Applications—812.36(c) .............................. 1 1 1 120 120
Treatment IDE Reporting—812.36(f) ................................... 1 1 1 20 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 Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper 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 Average
Number of Total annual
Activity/21 CFR section disclosures per burden per Total hours
respondents disclosures
respondent 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 SUMMARY: The Food and Drug and Radiological Health, Food and Drug
burden for this extension has decreased Administration’s (FDA) Center for Administration, 10903 New Hampshire
to 38,505 hours (previously 54,253 Devices and Radiological Health (CDRH Ave., Bldg. 32, Rm. 5261, Silver Spring,
hours) as the result of a decrease in the or Center) is announcing the 2016 MD 20993–0002, 240–402–2246, FAX:
average number of applications and Experiential Learning Program (ELP). 301–827–3079, Christian.Hussong@
supplements submitted. For the same This training component is intended to fda.hhs.gov.
reason, the recordkeeping burden has provide CDRH staff with an opportunity
SUPPLEMENTARY INFORMATION:
decreased to 7,800 hours (previously to understand the policies, laboratory
9,968). The previous approved total practices, and challenges faced in I. Background
burden hours of 64,227, have therefore broader disciplines that impact the CDRH is responsible for helping to
decreased by 17,916 to 46,311. device development life cycle. The ensure the safety and effectiveness of
Dated: March 4, 2016. purpose of this document is to invite medical devices marketed in the United
medical device industry, academia, and States. Furthermore, CDRH assures that
Leslie Kux,
health care facilities to request to patients and providers have timely and
Associate Commissioner for Policy.
participate in this formal training continued access to high-quality, safe,
[FR Doc. 2016–05385 Filed 3–9–16; 8:45 am] program for FDA’s medical device
BILLING CODE 4164–01–P
and effective medical devices. In
review staff, or to contact CDRH for support of this mission, the Center
more information regarding the ELP. launched various training and
DATES: Submit either an electronic or development initiatives to enhance
DEPARTMENT OF HEALTH AND
written request for participation in the performance of its staff involved in
HUMAN SERVICES
ELP by April 11, 2016. regulatory review and in the premarket
Food and Drug Administration ADDRESSES: Submit either electronic review process. One of these initiatives,
requests to http://www.regulations.gov the ELP Pilot, was launched in 2012 and
[Docket No. FDA–2015–N–0986] or written requests to the Division of fully implemented on April 2, 2013 (78
Dockets Management (HFA–305), Food
mstockstill on DSK4VPTVN1PROD with NOTICES
FR 19711).
Center for Devices and Radiological and Drug Administration, 5630 Fishers CDRH is committed to advancing
Health: Experiential Learning Program Lane, Rm. 1061, Rockville, MD 20852. regulatory science, providing industry
Identify requests with the docket with predictable, consistent,
AGENCY: Food and Drug Administration, number found in brackets in the transparent, and efficient regulatory
HHS. heading of this document. pathways, and helping to ensure
FOR FURTHER INFORMATION CONTACT: consumer confidence in medical
ACTION: Notice of availability.
Christian Hussong, Center for Devices devices marketed in the United States
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Document Created: 2018-02-02 15:12:16
Document Modified: 2018-02-02 15:12:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by April 11, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 12735 |
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