81 FR 50711 - Institutional Review Board Written Procedures: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Food and Drug Administration Federal Register Volume 81, Issue 148 (August 2, 2016)
Office of the Secretary
Food and Drug Administration
Federal Register Volume 81, Issue 148 (August 2, 2016)
| Page Range | 50711-50712 | |
| FR Document | 2016-18191 |
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)] [Notices] [Pages 50711-50712] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18191] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Food and Drug Administration [Docket No. FDA-2016-D-1605] Institutional Review Board Written Procedures: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability AGENCY: The Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, HHS, and the Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' The purpose of this draft guidance is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. The draft guidance is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 3, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions 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 manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions 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-2016-D-1605 for ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' 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. [[Page 50712]] 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. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. 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. SUPPLEMENTARY INFORMATION: I. Background OHRP and FDA are announcing the availability of a draft guidance document entitled ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' This guidance is intended to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. OHRP and FDA frequently receive requests for clarification regarding the scope and content of IRB written procedures. We recognize that procedures may vary among institutions and IRBs due to differences in the type of research studies reviewed by the IRB, institutional policy or administrative practices, number of IRBs at the institution, affiliation with an institution, and local and State laws and regulations. In order to provide guidance on the appropriate content of written procedures, while taking into account these variations, we created an IRB Written Procedures Checklist to assist IRBs in preparing and maintaining detailed written procedures suitable for their institutions. The IRB Written Procedures Checklist incorporates the HHS and FDA regulatory requirements for IRB written procedures and additional topics that we recommend including in written procedures. The draft guidance, when finalized, will supersede OHRP's July 1, 2011, ``Guidance on Written IRB Procedures'' and FDA's 1998 ``Appendix H: A Self-Evaluation Checklist for IRBs,'' (formerly part of FDA's Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors). To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies' regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts. OHRP and FDA believe that it will be most helpful to the regulated community to issue a joint guidance document that will clearly demonstrate the Agencies' harmonized approach to the topic of preparing and maintaining IRB written procedures. 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 OHRP's and FDA's current thinking on IRB written procedures. It does not establish any rights for any person and is not binding on OHRP, FDA, or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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 referenced in this guidance that are related to IRB recordkeeping requirements under 21 CFR 56.115, including the information collection activities in the provisions in 21 CFR 56.108(a)(1) and (b), have been approved under OMB control number 0910-0130. The collections of information referenced in this guidance that are related to IRB recordkeeping requirements under 45 CFR 46.115, including the information collection activities in the provisions in 45 CFR 46.103(b)(4) and (5) have been approved under OMB control number 0990- 0260. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm, http://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html, or http://www.regulations.gov. Dated: July 27, 2016. Leslie Kux, Associate Commissioner for Policy, U.S. Food and Drug Administration. Dated: July 15, 2016. Karen B. DeSalvo, Acting Assistant Secretary for Health, U.S. Department of Health and Human Services. [FR Doc. 2016-18191 Filed 8-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices 50711
safety or effectiveness (§ 314.162 (21 Accordingly, the Agency will guidance before it begins work on the
CFR 314.162)). continue to list SAMSCA (tolvaptan) final version of the guidance, submit
A person may petition the Agency to tablets, 60 mg, in the ‘‘Discontinued either electronic or written comments
determine, or the Agency may Drug Product List’’ section of the Orange on the draft guidance by October 3,
determine on its own initiative, whether Book. The ‘‘Discontinued Drug Product 2016.
a listed drug was withdrawn from sale List’’ delineates, among other items, ADDRESSES: You may submit comments
for reasons of safety or effectiveness. drug products that have been as follows:
This determination may be made at any discontinued from marketing for reasons
time after the drug has been withdrawn other than safety or effectiveness. Electronic Submissions
from sale, but must be made prior to ANDAs that refer to SAMSCA Submit electronic comments in the
approving an ANDA that refers to the (tolvaptan) tablets, 60 mg, may be following way:
listed drug (§ 314.161). FDA may not approved by the Agency as long as they • Federal eRulemaking Portal: http://
approve an ANDA that does not refer to meet all other legal and regulatory www.regulations.gov. Follow the
a listed drug. requirements for the approval of instructions for submitting comments.
SAMSCA (tolvaptan) tablets, 60 mg, ANDAs. If FDA determines that labeling Comments submitted electronically,
are the subject of NDA 22–275, held by for this drug product should be revised including attachments, to http://
Otsuka America Pharmaceutical, and to meet current standards, the Agency www.regulations.gov will be posted to
initially approved on May 19, 2009. will advise ANDA applicants to submit the docket unchanged. Because your
SAMSCA is indicated for the treatment such labeling. comment will be made public, you are
of clinically significant hypervolemic solely responsible for ensuring that your
and euvolemic hyponatremia (serum Dated: July 27, 2016.
comment does not include any
sodium <125 milliequivalents/liter or Leslie Kux,
confidential information that you or a
less marked hyponatremia that is Associate Commissioner for Policy. third party may not wish to be posted,
symptomatic and has resisted correction [FR Doc. 2016–18139 Filed 8–1–16; 8:45 am] such as medical information, your or
with fluid restriction), including BILLING CODE 4164–01–P anyone else’s Social Security number, or
patients with heart failure and confidential business information, such
syndrome of inappropriate antidiuretic as a manufacturing process. Please note
hormone (SIADH). DEPARTMENT OF HEALTH AND that if you include your name, contact
Otsuka America Pharmaceutical has HUMAN SERVICES information, or other information that
never marketed SAMSCA (tolvaptan) identifies you in the body of your
tablets, 60 mg. In previous instances Office of the Secretary
comments, that information will be
(see, e.g., 72 FR 9763 (March 5, 2007), posted on http://www.regulations.gov.
61 FR 25497 (May 21, 1996)), the Food and Drug Administration • If you want to submit a comment
Agency has determined that, for [Docket No. FDA–2016–D–1605] with confidential information that you
purposes of §§ 314.161 and 314.162, do not wish to be made available to the
never marketing an approved drug Institutional Review Board Written public, submit the comment as a
product is equivalent to withdrawing Procedures: Guidance for Institutions written/paper submission and in the
the drug from sale. and Institutional Review Boards; Draft manner detailed (see ‘‘Written/Paper
Gordon Johnston Regulatory Guidance; Availability Submissions’’ and ‘‘Instructions’’).
Consultants, LLC, submitted a citizen
petition dated March 15, 2016 (Docket AGENCY: The Office for Human Research Written/Paper Submissions
No. FDA–2016–P–0974), under 21 CFR Protections, Office of the Assistant Submit written/paper submissions as
10.30, requesting that the Agency Secretary for Health, Office of the follows:
determine whether SAMSCA (tolvaptan) Secretary, HHS, and the Food and Drug • Mail/Hand delivery/Courier (for
tablets, 60 mg, were withdrawn from Administration, HHS. written/paper submissions): Division of
sale for reasons of safety or ACTION: Notice of availability. Dockets Management (HFA–305), Food
effectiveness. and Drug Administration, 5630 Fishers
After considering the citizen petition SUMMARY: The Office for Human Lane, Rm. 1061, Rockville, MD 20852.
and reviewing Agency records and Research Protections (OHRP), Office of • For written/paper comments
based on the information we have at this the Assistant Secretary for Health, and submitted to the Division of Dockets
time, FDA has determined under the Food and Drug Administration Management, FDA will post your
§ 314.161 that SAMSCA (tolvaptan) (FDA) are announcing the availability of comment, as well as any attachments,
tablets, 60 mg, were not withdrawn for a draft guidance entitled ‘‘Institutional except for information submitted,
reasons of safety or effectiveness. The Review Board (IRB) Written Procedures: marked and identified, as confidential,
petitioner has identified no data or other Guidance for Institutions and IRBs.’’ if submitted as detailed in
information suggesting that SAMSCA The purpose of this draft guidance is to ‘‘Instructions.’’
(tolvaptan) tablets, 60 mg, were assist IRB administrators, IRB Instructions: All submissions received
withdrawn for reasons of safety or chairpersons, and other institutional must include the Docket No. FDA–
effectiveness. We have carefully officials responsible for preparing and 2016–D–1605 for ‘‘Institutional Review
reviewed our files for records maintaining written procedures for Board (IRB) Written Procedures:
concerning the withdrawal of SAMSCA IRBs. The draft guidance is intended for Guidance for Institutions and IRBs.’’
(tolvaptan) tablets, 60 mg, from sale. We IRBs and institutions responsible for Received comments will be placed in
mstockstill on DSK3G9T082PROD with NOTICES
have also independently evaluated review and oversight of human subject the docket and, except for those
relevant literature and data for possible research under the HHS or FDA submitted as ‘‘Confidential
postmarketing adverse events. We have regulations, or both. Submissions,’’ publicly viewable at
reviewed the available evidence and DATES: Although you can comment on http://www.regulations.gov or at the
determined that this drug product was any guidance at any time (see 21 CFR Division of Dockets Management
not withdrawn from sale for reasons of 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday
safety or effectiveness. considers your comment on this draft through Friday.
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![50712 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
• Confidential Submissions—To 200, Rockville, MD 20852, 240–453– person and is not binding on OHRP,
submit a comment with confidential 6900. FDA, or the public. You can use an
information that you do not wish to be SUPPLEMENTARY INFORMATION:
alternative approach if it satisfies the
made publicly available, submit your requirements of the applicable statutes
comments only as a written/paper I. Background and regulations.
submission. You should submit two OHRP and FDA are announcing the II. Paperwork Reduction Act of 1995
copies total. One copy will include the availability of a draft guidance
information you claim to be confidential This draft guidance refers to
document entitled ‘‘Institutional Review
with a heading or cover note that states previously approved collections of
Board (IRB) Written Procedures:
‘‘THIS DOCUMENT CONTAINS information. These collections of
Guidance for Institutions and IRBs.’’
CONFIDENTIAL INFORMATION.’’ The information are subject to review by the
This guidance is intended to assist IRB
Agency will review this copy, including Office of Management and Budget
administrators, IRB chairpersons, and
the claimed confidential information, in (OMB) under the Paperwork Reduction
other institutional officials responsible
its consideration of comments. The Act of 1995 (44 U.S.C. 3501–3520). The
for preparing and maintaining written
second copy, which will have the collections of information referenced in
procedures for IRBs.
claimed confidential information OHRP and FDA frequently receive this guidance that are related to IRB
redacted/blacked out, will be available requests for clarification regarding the recordkeeping requirements under 21
for public viewing and posted on http:// scope and content of IRB written CFR 56.115, including the information
www.regulations.gov. Submit both procedures. We recognize that collection activities in the provisions in
copies to the Division of Dockets procedures may vary among institutions 21 CFR 56.108(a)(1) and (b), have been
Management. If you do not wish your and IRBs due to differences in the type approved under OMB control number
name and contact information to be of research studies reviewed by the IRB, 0910–0130. The collections of
made publicly available, you can institutional policy or administrative information referenced in this guidance
provide this information on the cover practices, number of IRBs at the that are related to IRB recordkeeping
sheet and not in the body of your institution, affiliation with an requirements under 45 CFR 46.115,
comments and you must identify this institution, and local and State laws and including the information collection
information as ‘‘confidential.’’ Any regulations. In order to provide activities in the provisions in 45 CFR
information marked as ‘‘confidential’’ guidance on the appropriate content of 46.103(b)(4) and (5) have been approved
will not be disclosed except in written procedures, while taking into under OMB control number 0990–0260.
accordance with 21 CFR 10.20 and other account these variations, we created an III. Electronic Access
applicable disclosure law. For more IRB Written Procedures Checklist to
information about FDA’s posting of Persons with access to the Internet
assist IRBs in preparing and maintaining may obtain the draft guidance at either
comments to public dockets, see 80 FR detailed written procedures suitable for
56469, September 18, 2015, or access http://www.fda.gov/ScienceResearch/
their institutions. The IRB Written SpecialTopics/RunningClinicalTrials/
the information at: http://www.fda.gov/ Procedures Checklist incorporates the
regulatoryinformation/dockets/ ProposedRegulationsandDraft
HHS and FDA regulatory requirements Guidances/default.htm, http://www.hhs.
default.htm. for IRB written procedures and
Docket: For access to the docket to gov/ohrp/regulations-and-policy/
additional topics that we recommend requests-for-comments/index.html, or
read background documents or the including in written procedures. The
electronic and written/paper comments http://www.regulations.gov.
draft guidance, when finalized, will
received, go to http:// supersede OHRP’s July 1, 2011, Dated: July 27, 2016.
www.regulations.gov and insert the ‘‘Guidance on Written IRB Procedures’’ Leslie Kux,
docket number, found in brackets in the and FDA’s 1998 ‘‘Appendix H: A Self- Associate Commissioner for Policy, U.S. Food
heading of this document, into the Evaluation Checklist for IRBs,’’ and Drug Administration.
‘‘Search’’ box and follow the prompts (formerly part of FDA’s Information Dated: July 15, 2016.
and/or go to the Division of Dockets Sheet Guidance for IRBs, Clinical Karen B. DeSalvo,
Management, 5630 Fishers Lane, Rm. Investigators, and Sponsors). Acting Assistant Secretary for Health, U.S.
1061, Rockville, MD 20852. To enhance human subject protection Department of Health and Human Services.
Submit written requests for single and reduce regulatory burden, OHRP [FR Doc. 2016–18191 Filed 8–1–16; 8:45 am]
copies of the draft guidance to the and FDA have been actively working to BILLING CODE 4164–01–P
Division of Drug Information, Center for harmonize the Agencies’ regulatory
Drug Evaluation and Research, Food requirements and guidance for human
and Drug Administration, 10001 New subject research. This guidance DEPARTMENT OF HEALTH AND
Hampshire Ave., Hillandale Building, document was developed as a part of HUMAN SERVICES
4th Floor, Silver Spring, MD 20993– these efforts. OHRP and FDA believe
0002. Send one self-addressed adhesive that it will be most helpful to the Advisory Council on Alzheimer’s
label to assist that office in processing regulated community to issue a joint Research, Care, and Services; Meeting
your requests. See the SUPPLEMENTARY guidance document that will clearly AGENCY: Assistant Secretary for
INFORMATION section for electronic demonstrate the Agencies’ harmonized Planning and Evaluation, HHS.
access to the draft guidance document. approach to the topic of preparing and ACTION: Notice of meeting.
FOR FURTHER INFORMATION CONTACT: maintaining IRB written procedures.
mstockstill on DSK3G9T082PROD with NOTICES
Janet Donnelly, Office of Good Clinical This draft guidance is being issued SUMMARY: This notice announces the
Practice, Food and Drug Administration, consistent with FDA’s good guidance public meeting of the Advisory Council
10903 New Hampshire Ave., Bldg. 32, practices regulation (21 CFR 10.115). on Alzheimer’s Research, Care, and
Rm. 5167, Silver Spring, MD 20993– The draft guidance, when finalized, will Services (Advisory Council). The
0002, 301–796–4187; or Irene Stith- represent OHRP’s and FDA’s current Advisory Council on Alzheimer’s
Coleman, Office for Human Research thinking on IRB written procedures. It Research, Care, and Services provides
Protections, 1101 Wootton Pkwy., Suite does not establish any rights for any advice on how to prevent or reduce the
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Document Created: 2016-08-02 01:47:28
Document Modified: 2016-08-02 01:47:28
| 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 of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 3, 2016. | |
| 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. | |
| FR Citation | 81 FR 50711 |
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