Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed; Availability, 69631-69632 [2012-28149]

Download as PDF 69631 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices TABLE 1—NADAS: ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section/FDA Form No. 514.5(b), (d), and (f) Requesting presubmission conferences ........................................................................ 514.1 and 514.6 Applications and amended applications 514.8(b) Manufacturing changes to an approved application ............................................................................ 514.8(c)(1) Labeling and other changes to an approved application .................................................................... 514.8(c)(2) and (3) Labeling and other changes to an approved application .................................................... 514.11 Submission of data, studies and other information ................................................................................ 558.5(i) Requirements for liquid medicated feed ............ 514.1(b)(8) and 514.8(c)(1) 2 Evidence to establish safety and effectiveness ..................................................... FDA Form 356V ............................................................... Total .......................................................................... Number of responses per respondent Total annual responses Average burden per response Total hours 169 169 0.41 0.07 69 12 50 212 3,450 2,544 169 2.22 375 35 13,125 169 0.06 10 71 710 169 0.72 121 20 2,420 169 169 0.08 0.01 169 169 0.15 4.37 ........................ ........................ 14 1.7 1 5 25 739 .......................... 14 8.5 90 5 2,250 3,695 ........................ 28,217 1 There are no capital costs or operating and maintenance costs associated with this collection of information. and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the overall preapproval safety evaluation. 2 NADAs Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 169 annual respondents during the 5 fiscal years, from October 1, 2008 through September 30, 2012, on which these estimates were made. We use this estimate consistently throughout the table and calculate the ‘‘total annual responses’’ by multiplying the number of responses per respondent by number of respondents. Dated: November 15, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–28199 Filed 11–19–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0847] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed; Availability AGENCY: Food and Drug Administration, HHS. wreier-aviles on DSK5TPTVN1PROD with ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the SUMMARY: VerDate Mar<15>2010 17:49 Nov 19, 2012 Jkt 229001 Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.’’ The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. 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 January 22, 2013. Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002 (1–888– 463–6332 or 301–796–3400); or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448 (1–800–835–4709 or 301–827–1800); or the Division of Small ADDRESSES: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993 (1–800–638– 2041 or 301–796–7100). Send one selfaddressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance 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: Doreen Kezer, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5109, Silver Spring, MD 20993, 301–796–8524. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.’’ This guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated E:\FR\FM\20NON1.SGM 20NON1 wreier-aviles on DSK5TPTVN1PROD with 69632 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices products in determining that the proposed research satisfies the criteria for approval contained in 21 CFR 56.111, that ‘‘* * * the risks to subjects are minimized * * * and reasonable in relation to anticipated benefits, if any, to subjects * * *.’’ In particular, the guidance addresses the IRB’s role in reviewing: (1) The qualifications of investigators, (2) the adequacy of the research site, and (3) the determination of whether an IND/IDE is needed. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance entitled ‘‘Institutional Review Boards Frequently Asked Questions— Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.’’ 1 FDA is issuing this as a draft guidance. Although many of these recommendations have appeared in other FDA guidance documents, FDA has compiled the information here in order to assure that all IRBs are aware of and have access to it. The guidance also explains how IRBs may efficiently fulfill these important responsibilities. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (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 and in consultation with OHRP. In addition, FDA acknowledges HHS’s publication of the advanced notice of proposed rulemaking (ANPRM), ‘‘Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,’’ in the Federal Register of July 26, 2011 (76 FR 44512). In the ANPRM, HHS sought comment on whether the Federal human subject protection regulations should be modified in a number of ways. In finalizing this draft guidance, ‘‘IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed,’’ FDA intends to consider relevant public comments submitted in response to both the draft guidance and the ANPRM. The draft guidance is being issued consistent with FDA’s Good Guidance Practices (GGPs) regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current 1 See https://www.fda.gov/RegulatoryInformation/ Guidances/ucm126420.htm#GeneralQuestions. VerDate Mar<15>2010 15:12 Nov 19, 2012 Jkt 229001 thinking on this topic. 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 statutes and regulations. II. The Paperwork Reduction Act of 1995 This draft guidance includes information collections provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) 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 have been approved under OMB control number 0910–0130; the collections of information under 21 CFR Part 312 have been approved under OMB control number 0910–0014; and the collections of information under 21 CFR Part 812 have been approved under OMB control number 0910–0078. In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to these previously approved collections of information found in FDA regulations. III. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/ScienceResearch/Special Topics/RunningClinicalTrials/ ProposedRegulationsand DraftGuidances/default.htm or https:// www.regulations.gov. Dated: November 15, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–28149 Filed 11–19–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0643] Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Electronic Source Data in Clinical Investigations.’’ This document revises and updates the draft guidance entitled ‘‘Electronic Source Documentation in Clinical Investigations.’’ This revised draft document provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the revised draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within January 22, 2013. ADDRESSES: Submit written requests for single copies of the revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448; Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002; and Office of Critical Path Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4173, Silver Spring, SUMMARY: E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69631-69632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28149]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0847]

Draft Guidance for IRBs, Clinical Investigators, and Sponsors:
IRB Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the Determination of Whether an IND/IDE
Is Needed; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for IRBs, Clinical
Investigators, and Sponsors: IRB Responsibilities for Reviewing the
Qualifications of Investigators, Adequacy of Research Sites, and the
Determination of Whether an IND/IDE Is Needed.'' The draft guidance
announced in this notice is intended to assist institutional review
boards (IRBs), clinical investigators, and sponsors involved in
clinical investigations of FDA-regulated products in fulfilling
responsibilities related to reviewing the qualifications of
investigators, adequacy of research sites, and the determination of
whether an investigational new drug (IND) application or
investigational device exemption (IDE) is needed in order to assure the
protection of the rights and welfare of human subjects in clinical
investigations.

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 January 22, 2013.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or 301-796-3400); or the Office of Communication, Outreach
and Development (HFM-40), Center for Biologics Evaluation and Research,
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448 (1-800-835-4709 or 301-827-1800); or the
Division of Small Manufacturers, International and Consumer Assistance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver
Spring, MD 20993 (1-800-638-2041 or 301-796-7100). Send one self-
addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance 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: Doreen Kezer, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5109, Silver Spring, MD 20993, 301-796-8524.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance entitled
``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB
Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the Determination of Whether an IND/IDE
Is Needed.'' This guidance is intended to assist IRBs, clinical
investigators, and sponsors involved in clinical investigations of FDA-
regulated

[[Page 69632]]

products in determining that the proposed research satisfies the
criteria for approval contained in 21 CFR 56.111, that ``* * * the
risks to subjects are minimized * * * and reasonable in relation to
anticipated benefits, if any, to subjects * * *.'' In particular, the
guidance addresses the IRB's role in reviewing: (1) The qualifications
of investigators, (2) the adequacy of the research site, and (3) the
determination of whether an IND/IDE is needed. When finalized, this
guidance will supersede Question 56 in FDA's January 1998 guidance
entitled ``Institutional Review Boards Frequently Asked Questions--
Information Sheet Guidance for Institutional Review Boards and Clinical
Investigators.'' \1\
---------------------------------------------------------------------------

\1\ See https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#GeneralQuestions.
---------------------------------------------------------------------------

FDA is issuing this as a draft guidance. Although many of these
recommendations have appeared in other FDA guidance documents, FDA has
compiled the information here in order to assure that all IRBs are
aware of and have access to it. The guidance also explains how IRBs may
efficiently fulfill these important responsibilities.
To enhance human subject protection and reduce regulatory burden,
the Department of Health and Human Services (HHS) Office for Human
Research Protections (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 and in consultation with OHRP. In addition, FDA
acknowledges HHS's publication of the advanced notice of proposed
rulemaking (ANPRM), ``Human Subjects Research Protections: Enhancing
Protections for Research Subjects and Reducing Burden, Delay, and
Ambiguity for Investigators,'' in the Federal Register of July 26, 2011
(76 FR 44512). In the ANPRM, HHS sought comment on whether the Federal
human subject protection regulations should be modified in a number of
ways. In finalizing this draft guidance, ``IRB Responsibilities for
Reviewing the Qualifications of Investigators, Adequacy of Research
Sites, and the Determination of Whether an IND/IDE Is Needed,'' FDA
intends to consider relevant public comments submitted in response to
both the draft guidance and the ANPRM.
The draft guidance is being issued consistent with FDA's Good
Guidance Practices (GGPs) regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent FDA's current thinking on this
topic. 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
statutes and regulations.

II. The Paperwork Reduction Act of 1995

This draft guidance includes information collections provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) 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 have been
approved under OMB control number 0910-0130; the collections of
information under 21 CFR Part 312 have been approved under OMB control
number 0910-0014; and the collections of information under 21 CFR Part
812 have been approved under OMB control number 0910-0078. In
accordance with the PRA, prior to publication of any final guidance
document, FDA intends to solicit public comment and obtain OMB approval
for any information collections recommended in this guidance that are
new or that would represent material modifications to these previously
approved collections of information found in FDA regulations.

III. Comments

Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. 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.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm or https://www.regulations.gov.

Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28149 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P

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