Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 30965 [2020-10977]

Download as PDF Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices Food and Drug Administration [Docket Nos. FDA–2014–N–1533; FDA– 2019–N–2313; FDA–2013–N–0825; FDA– 2013–N–1427; FDA–2013–N–1393; FDA– 2013–N–0719; FDA–2013–N–0796; and FDA–2018–D–4711] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. The following is a list of FDA information collections recently approved by OMB SUPPLEMENTARY INFORMATION: 30965 under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at http://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection National Panel of Tobacco Consumer Studies ....................................................................................................... Study of Oncology Indications in Direct-to-Consumer Television Advertising ........................................................ Premarket Approval of Medical Devices ................................................................................................................. Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing of Juice ............... Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................ Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products ...... Testing Communications on Medical Devices and Radiation-Emitting Products ................................................... Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments ............................. Dated: May 18, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–10977 Filed 5–20–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1291] Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice; Public Web Conference AGENCY: Food and Drug Administration, HHS. Notice of public web conference. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is announcing a free public web conference for discussion of the International Council for Harmonisation’s (ICH’s) good clinical practice guidelines, ICH E6. This public web conference, ‘‘Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice,’’ is being convened and supported by a cooperative agreement between the Clinical Trials Transformation Initiative (CTTI) and FDA. The purpose of the web conference is to capture SUMMARY: VerDate Sep<11>2014 17:18 May 20, 2020 Jkt 250001 stakeholder experiences with current ICH E6 guidelines for good clinical practice (GCP) and to gather stakeholder input to further inform the development of an updated guideline, ICH E6(R3). DATES: The public web conference will be held on Thursday and Friday, June 4 and 5, 2020, from 10 a.m. to 1 p.m. Eastern Time. Further details on the web conference (including times) are available at the website provided under ADDRESSES. See the SUPPLEMENTARY INFORMATION section for details. ADDRESSES: The web conference will be held online. Meeting details and background materials, including the web conference link, are available at the following website: https://www.ctticlinicaltrials.org/briefing-room/ meetings/ich-e6-guideline-good-clinicalpractice-stakeholder-engagement. FOR FURTHER INFORMATION CONTACT: Suzanne Pattee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3328, Silver Spring, MD 20993, 301–796– 1706, Suzanne.Pattee@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background To support GCP renovation, FDA and ICH are seeking stakeholder input to develop a new ICH guideline, ‘‘ICH E6(R3): Guideline for Good Clinical Practice,’’ to enable flexible application PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 0910–0815 0910–0885 0910–0231 0910–0466 0910–0233 0910–0675 0910–0678 0910–0886 Date approval expires 2/28/2023 2/28/2023 3/31/2023 3/31/2023 4/30/2023 4/30/2023 4/30/2023 4/30/2023 of those guidelines to interventional clinical trials, including innovative clinical trial designs and data sources. ICH E6(R3) materials, including the ICH Reflection Paper on ‘‘GCP Renovation,’’ concept paper, business plan, work plan, and an expert list, as well as the current guideline, ‘‘ICH E6(R2): Guideline for Good Clinical Practice,’’ are available on the ICH website: https://www.ich.org/page/efficacyguidelines. The purpose of the public web conference announced in this notice is to obtain input on stakeholder experiences with the current GCP guideline (ICH E6(R2)) and suggested changes to improve the guideline’s applicability to the changing clinical trial landscape. II. Topics for Discussion at the Public Web Conference During the public web conference, speakers and participants will cover a range of GCP issues to inform revisions to the current GCP guidelines. Topics for discussion will include and are not limited to: (1) Issues with application of current guidelines to traditional interventional clinical trials, (2) ways to modify the guideline to address innovative trial designs, (3) use of digital technology tools, (4) new data sources, and (5) other topics relating to GCPs. E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Page 30965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10977]



[[Page 30965]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-N-1533; FDA-2019-N-2313; FDA-2013-N-0825; FDA-
2013-N-1427; FDA-2013-N-1393; FDA-2013-N-0719; FDA-2013-N-0796; and 
FDA-2018-D-4711]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at http://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
National Panel of Tobacco Consumer             0910-0815       2/28/2023
 Studies................................
Study of Oncology Indications in Direct-       0910-0885       2/28/2023
 to-Consumer Television Advertising.....
Premarket Approval of Medical Devices...       0910-0231       3/31/2023
Hazard Analysis and Critical Control           0910-0466       3/31/2023
 Point Procedures for the Safe and
 Sanitary Processing of Juice...........
Patent Term Restoration, Due Diligence         0910-0233       4/30/2023
 Petitions, Filing, Format, and Content
 of Petitions...........................
Planning for the Effects of High               0910-0675       4/30/2023
 Absenteeism to Ensure Availability of
 Medically Necessary Drug Products......
Testing Communications on Medical              0910-0678       4/30/2023
 Devices and Radiation-Emitting Products
Requests for Nonbinding Feedback After         0910-0886       4/30/2023
 Certain FDA Inspections of Device
 Establishments.........................
------------------------------------------------------------------------


    Dated: May 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10977 Filed 5-20-20; 8:45 am]
 BILLING CODE 4164-01-P