80 FR 41044 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 134 (July 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 134 (July 14, 2015)
| Page Range | 41044-41046 | |
| FR Document | 2015-17318 |
[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)] [Notices] [Pages 41044-41046] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17318] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0597] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring 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 the collection of information concerning the development of comprehensive monitoring plans in the guidance. DATES: Submit either electronic or written comments on the collection of information by September 14, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the 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 [[Page 41045]] Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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 on Oversight of Clinical Investigations: A Risk- Based Approach To Monitoring (OMB Control Number 0910-0733)--Extension The guidance is intended to assist sponsors of clinical investigations in developing strategies for risk-based monitoring and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. The guidance describes strategies for monitoring activities performed by sponsors, or by contract research organizations (CROs), that focus on the conduct, oversight, and reporting of findings of an investigation by clinical investigators. The guidance also recommends strategies that reflect a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. The guidance specifically encourages greater reliance on centralized monitoring methods where appropriate. Under parts 312 and 812 (21 CFR parts 312 and 812), sponsors are required to provide appropriate oversight of their clinical investigations to ensure adequate protection of the rights, welfare, and safety of human subjects and to ensure the quality and integrity of the resulting data submitted to FDA. As part of this oversight, sponsors of clinical investigations are required to monitor the conduct and progress of their clinical investigations. The regulations do not specify how sponsors are to conduct monitoring of clinical investigations and, therefore, are compatible with a range of approaches to monitoring. FDA currently has OMB approval for the information collection required under part 812 (OMB control number 0910-0078) and part 312, including certain provisions under subpart D (OMB control number 0910-0014). The collection of information associated with this guidance that approved under OMB control number 0910-0733 is as follows: Development of Comprehensive Monitoring Plan: Section IV.D ``Monitoring Plan'' of the guidance recommends that sponsors develop a prospective, detailed monitoring plan that describes the monitoring methods, responsibilities, and requirements for each clinical trial. The plan should provide adequate information to those involved with monitoring to effectively carry out their duties. All sponsor personnel and CRO personnel who may be involved with monitoring (including those who review appropriate action, determine appropriate action, or both regarding potential issues identified through monitoring) should review the monitoring plan. The components of a monitoring plan are described in the guidance, including monitoring plan amendments (i.e., the review and revision of monitoring plans and processes for timely updates). FDA understands that sponsors currently develop monitoring plans; however, not all monitoring plans contain all the elements described in the guidance. Therefore, our burden estimate provides the additional time that a sponsor would expend in developing a comprehensive monitoring plan based on the recommendations in the guidance. FDA estimates that approximately 88 sponsors will develop approximately 132 comprehensive monitoring plans in accordance with the guidance and that the added burden for each plan will be approximately 4 hours to develop, including the time needed to prepare monitoring plan amendments when appropriate (a total of 528 hours). FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Development of Comprehensive Monitoring Plan....................... 88 1.5 132 4 528 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 41046]] Dated: July 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-17318 Filed 7-13-15; 8:45 am] BILLING CODE 4164-01-P
![41044 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
Annual Responses: 861; Total Annual Description: This statistical report is child; and an unduplicated count of
Hours: 12,930. (For policy questions an annual activity required by statute assisted households receiving one or
regarding this collection contact Jaya (42 U.S.C. 8629) and Federal regulations more types of LIHEAP assistance.
Ghildiyal at (301) 492–5149.) (45 CFR 96.92) for the Low Income Insular areas receiving less than
Dated: July 9, 2015. Home Energy Assistance Program $200,000 annually in LIHEAP funds and
(LIHEAP). Submission of the completed Indian Tribal Grantees are required to
William N. Parham, III,
report is one requirement for LIHEAP submit data only on the number of
Director, Paperwork Reduction Staff, Office
grantees applying for Federal LIHEAP households receiving heating, cooling,
of Strategic Operations and Regulatory
Affairs. block grant funds. States, the District of
energy crisis, or weatherization benefits.
Columbia, and the Commonwealth of
[FR Doc. 2015–17285 Filed 7–10–15; 11:15 am] The information is being collected for
Puerto Rico are required to report
BILLING CODE 4120–01–P the Department’s annual LIHEAP report
statistics for the previous Federal fiscal
to Congress. The data also provides
year on the number and income levels
information about the need for LIHEAP
of LIHEAP applicants and assisted
DEPARTMENT OF HEALTH AND funds. Finally, the data are used in the
households, as well as the number of
HUMAN SERVICES calculation of LIHEAP performance
LIHEAP-assisted households with at
least one member who is elderly, measures under the Government
Administration for Children and Performance and Results Act of 1993.
Families disabled, or a young child.
The statistical report requires States, The additional data elements will
the District of Columbia, and the improve the accuracy of measuring
Submission for OMB Review;
Commonwealth of Puerto Rico to report LIHEAP targeting performance and
Comment Request
on assisted households having at least LIHEAP cost efficiency.
Title: Annual Report on Households one elderly person who is homebound; Respondents: State Governments,
Assisted by the Low Income Home an unduplicated count of assisted Tribal Governments, Insular Areas, the
Energy Assistance Program (LIHEAP) households having at least one member District of Columbia, and the
OMB No.: 0970–0060. who is elderly, disabled, or a young Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per respond- hours
per response
ent
Assisted household Report-Long Form ........................................................... 52 1 25 1,300
Assisted Household Report-Short Form .......................................................... 155 1 1 155
Applicant Household Report ............................................................................ 52 1 13 676
Estimated Total Annual Burden Desk Officer for the Administration for Paperwork Reduction Act of 1995 (the
Hours: 2,131. Children and Families. PRA), Federal Agencies are required to
publish notice in the Federal Register
Additional Information Robert Sargis,
concerning each proposed collection of
Copies of the proposed collection may Reports Clearance Officer. information, including each proposed
be obtained by writing to the [FR Doc. 2015–17166 Filed 7–13–15; 8:45 am] extension of an existing collection of
Administration for Children and BILLING CODE 4184–01–P information, and to allow 60 days for
Families, Office of Planning, Research public comment in response to the
and Evaluation, 370 L’Enfant notice. This notice solicits comments on
Promenade, SW., Washington, DC DEPARTMENT OF HEALTH AND the collection of information concerning
20447, Attn: ACF Reports Clearance HUMAN SERVICES the development of comprehensive
Officer. All requests should be monitoring plans in the guidance.
identified by the title of the information Food and Drug Administration
DATES: Submit either electronic or
collection. Email address: written comments on the collection of
[Docket No. FDA–2011–D–0597]
infocollection@acf.hhs.gov. information by September 14, 2015.
OMB Comment Agency Information Collection ADDRESSES: Submit electronic
Activities; Proposed Collection; comments on the collection of
OMB is required to make a decision
Comment Request; Guidance for information to http://
concerning the collection of information
Industry on Oversight of Clinical www.regulations.gov. Submit written
between 30 and 60 days after
Investigations: A Risk-Based comments on the collection of
publication of this document in the
Approach To Monitoring information to the Division of Dockets
Federal Register. Therefore, a comment
is best assured of having its full effect Food and Drug Administration, Management (HFA–305), Food and Drug
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY:
if OMB receives it within 30 days of HHS. Administration, 5630 Fishers Lane, rm.
publication. Written comments and 1061, Rockville, MD 20852. All
ACTION: Notice.
recommendations for the proposed comments should be identified with the
information collection should be sent SUMMARY: The Food and Drug docket number found in brackets in the
directly to the following: Office of Administration (FDA) is announcing an heading of this document.
Management and Budget, Paperwork opportunity for public comment on the FOR FURTHER INFORMATION CONTACT: FDA
Reduction Project , Email: OIRA_ proposed collection of certain PRA Staff, Office of Operations, Food
SUBMISSION@OMB.EOP.GOV, Attn: information by the Agency. Under the and Drug Administration, 8455
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![41046 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
Dated: July 9, 2015. Administration, 5630 Fishers Lane, Rm. diagnostic device. The information in
Leslie Kux, 1061, Rockville, MD 20852. Identify this draft guidance document is also
Associate Commissioner for Policy. comments with the docket number applicable to the MRI system
[FR Doc. 2015–17318 Filed 7–13–15; 8:45 am] found in brackets in the heading of this components of dual-modality devices,
BILLING CODE 4164–01–P
document. such as positron emission tomography/
FOR FURTHER INFORMATION CONTACT: Jana MRI systems.
Delfino, Center for Devices and II. Significance of Guidance
DEPARTMENT OF HEALTH AND Radiological Health, Food and Drug
HUMAN SERVICES Administration, 10903 New Hampshire This draft guidance is being issued
Ave., Bldg. 66, Rm. 4236, Silver Spring, consistent with FDA’s good guidance
Food and Drug Administration MD 20993–0002, 301–796–6503; or practices regulation (21 CFR 10.115).
Sunder Rajan, Center for Devices and The draft guidance, when finalized, will
[Docket No. FDA–2015–D–2148]
Radiological Health, Food and Drug represent the current thinking of FDA
Submission of Premarket Notifications Administration, 10903 New Hampshire on ‘‘Submission of Premarket
for Magnetic Resonance Diagnostic Ave., Bldg. 62, Rm. 1113, Silver Spring, Notifications for Magnetic Resonance
Devices; Draft Guidance for Industry MD 20993–0002, 301–796–4194. Diagnostic Devices.’’ It does not
and Food and Drug Administration establish any rights for any person and
SUPPLEMENTARY INFORMATION:
Staff; Availability is not binding on FDA or the public.
I. Background You can use an alternative approach if
AGENCY: Food and Drug Administration, it satisfies the requirements of the
The purpose of this document is to
HHS. applicable statutes and regulations.
provide a detailed description of the
ACTION: Notice. information that should be included in III. Electronic Access
SUMMARY: The Food and Drug a premarket notification for an MRDD. Persons interested in obtaining a copy
Administration (FDA) is announcing the This document is an elaboration of the of the draft guidance may do so by
availability of a draft guidance entitled general requirements contained in 21 downloading an electronic copy from
‘‘Submission of Premarket Notifications CFR 807.87 and is intended to be used the Internet. A search capability for all
for Magnetic Resonance Diagnostic in conjunction with general information Center for Devices and Radiological
Devices.’’ This draft guidance provides regarding the content and format of a Health guidance documents is available
a detailed description of the information 510(k) premarket notification. The at http://www.fda.gov/MedicalDevices/
that should be included in a premarket approach outlined in this guidance DeviceRegulationandGuidance/
notification for a magnetic resonance document is intended to facilitate the GuidanceDocuments/default.htm.
diagnostic device (MRDD). This draft timely review and marketing clearance Guidance documents are also available
guidance is not final nor is it in effect of MRDDs. at http://www.regulations.gov. Persons
at this time. This draft guidance is applicable to unable to download an electronic copy
MRDDs as defined in 21 CFR 892.1000. of ‘‘Submission of Premarket
DATES: Although you can comment on
An MRDD is intended for general Notifications for Magnetic Resonance
any guidance at any time (see 21 CFR diagnostic use to present images that
10.115(g)(5)), to ensure that the Agency Diagnostic Devices’’ may send an email
reflect the spatial distribution and/or request to CDRH-Guidance@fda.hhs.gov
considers your comment of this draft magnetic resonance spectra that reflect
guidance before it begins work on the to receive an electronic copy of the
frequency and distribution of nuclei document. Please use the document
final version of the guidance, submit exhibiting nuclear magnetic resonance.
either electronic or written comments number 340 to identify the guidance
Other physical parameters derived from you are requesting.
on the draft guidance by October 13, the images and/or spectra may also be
2015. produced. The device includes IV. Paperwork Reduction Act of 1995
ADDRESSES: An electronic copy of the hydrogen-1 (proton) imaging, sodium-23 This draft guidance refers to
guidance document is available for imaging, hydrogen-1 spectroscopy, previously approved collections of
download from the Internet. See the phosphorus-31 spectroscopy, and information found in FDA regulations.
SUPPLEMENTARY INFORMATION section for chemical shift imaging (preserving These collections of information are
information on electronic access to the simultaneous frequency and spatial subject to review by the Office of
guidance. Submit written requests for a information). MRDDs are class II Management and Budget (OMB) under
single hard copy of the draft guidance medical devices that require premarket the Paperwork Reduction Act of 1995
document entitled ‘‘Guidance for the notification and an agency (44 U.S.C. 3501–3520). The collections
Submission of Premarket Notifications determination of substantial of information in 21 CFR part 807,
for Magnetic Resonance Diagnostic equivalence prior to marketing. subpart E, have been approved under
Devices’’ to the Office of the Center The principal components of current OMB control number 0910–0120, and
Director, Guidance and Policy MRDDs include the main magnet, shim the collections of information in 21 CFR
Development, Center for Devices and and gradient systems, radiofrequency part 801 have been approved under
Radiological Health, Food and Drug transmitter and receiver, transmit and OMB control number 0910–0485.
Administration, 10903 New Hampshire receive coils, power supplies, computer,
Ave., Bldg. 66, Rm. 5431, Silver Spring, and software. This draft guidance V. Comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
MD 20993–0002. Send one self- document is applicable to premarket Interested persons may submit either
addressed adhesive label to assist that notifications for new magnetic electronic comments regarding this
office in processing your request. resonance imaging (MRI) and magnetic document to http://www.regulations.gov
Submit electronic comments on the resonance spectroscopy systems, new or written comments to the Division of
draft guidance to http:// components, and modifications to Dockets Management (see ADDRESSES). It
www.regulations.gov. Submit written systems and components that have a is only necessary to send one set of
comments to the Division of Dockets significant impact on safety or comments. Identify comments with the
Management (HFA–305), Food and Drug effectiveness of the magnetic resonance docket number found in brackets in the
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Document Created: 2018-02-23 09:19:36
Document Modified: 2018-02-23 09:19:36
| 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 | Submit either electronic or written comments on the collection of information by September 14, 2015. | |
| 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 | 80 FR 41044 |
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