The Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, and the Food and Drug Administration, HHS.
Notice of availability; extension of comment period.
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are extending the comment period for the draft guidance entitled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of November 5, 2015. The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. This extension will allow interested persons additional time to submit comments.
OHRP and FDA are extending the comment period on the draft guidance entitled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” Submit either electronic or written comments by February 3, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the Start Printed Page 78239manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2015-D-3638 for “Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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FOR FURTHER INFORMATION CONTACT:
Janet Donnelly, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5167, Silver Spring, MD 20993-0002, 301-796-4187; or Irene Stith-Coleman, Office for Human Research Protections, 1101 Wootton Pkwy., Suite 200, Rockville, MD 20852, 240-453-6900.
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In the Federal Register of November 5, 2015 (80 FR 68545), OHRP and FDA published a notice of availability with a 60-day comment period to request comments on a draft guidance document entitled “Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability.” The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. We believe that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance on these important issues.
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Dated: December 9, 2015.
Associate Commissioner for Policy, U.S. Food and Drug Administration.
Dated: December 4, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, U.S. Department of Health and Human Services.
[FR Doc. 2015-31593 Filed 12-15-15; 8:45 am]
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