Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period, 57940 [2014-22951]

Download as PDF 57940 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices particular diagnosis, prognosis, and monitoring or risk assessment. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on content and format for abbreviated 510(k)s for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. mstockstill on DSK4VPTVN1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400030 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, are currently approved under OMB control number 0910–0120 and the collections of information in 21 CFR part 809.10 are currently approved under 0910–0485. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of VerDate Sep<11>2014 19:14 Sep 25, 2014 Jkt 232001 comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: September 22, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22973 Filed 9–25–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2006–D–0031] Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled ‘‘Informed Consent Information Sheet.’’ A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information. DATES: Submit either electronic or written comments by October 27, 2014. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Marsha Melvin, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Building 32, Silver Spring, MD 20993, marsha.melvin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In the Federal Register of July 15, 2014 (79 FR 41291), FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance document entitled ‘‘Informed Consent Information Sheet.’’ PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 The Agency has received a request for a 30-day extension of the comment period for the draft guidance. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance. FDA is reopening the comment period for 30 days. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance on these important issues. II. Request for Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: September 19, 2014 Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22951 Filed 9–25–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2014–M–0327, FDA– 2014–M–0434, FDA–2014–M–0552, FDA– 2014–M–0553, FDA–2014–M–0690; FDA– 2014–M–0691, FDA–2014–M–0692, FDA– 2014–M–0726, FDA–2014–M–0727, FDA– 2014–M–0866, and FDA–2014–M–0872] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and SUMMARY: E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Page 57940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22951]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0031]


Draft Informed Consent Information Sheet: Guidance for 
Institutional Review Boards, Clinical Investigators, and Sponsors; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the draft guidance document entitled ``Informed 
Consent Information Sheet.'' A notice of availability requesting 
comments on the draft guidance document appeared in the Federal 
Register of July 15, 2014. The Agency is reopening the comment period 
to update comments and to receive any new information.

DATES: Submit either electronic or written comments by October 27, 
2014.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marsha Melvin, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., 
Building 32, Silver Spring, MD 20993, marsha.melvin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2014 (79 FR 41291), FDA 
published a notice of availability with a 60-day comment period to 
request comments on the draft guidance document entitled ``Informed 
Consent Information Sheet.''
    The Agency has received a request for a 30-day extension of the 
comment period for the draft guidance. The request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the draft guidance.
    FDA is reopening the comment period for 30 days. The Agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying finalizing 
the guidance on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

    Dated: September 19, 2014
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22951 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P
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