Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability, 29781-29782 [2014-11923]

Download as PDF Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices available. Funding beyond the first year will be noncompetitive and will depend on: (1) Satisfactory performance during the preceding year and (2) the availability of Federal fiscal year funds. Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect): Year 01: $7,500,000 Year 02: $7,500,000 Year 03: $7,500,000 Year 04: $7,500,000 Year 05: $7,500,000 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.’’ The guidance announced in this document discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. The guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 selfaddressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. SUMMARY: III. Electronic Application, Registration, and Submission Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at https:// www.grants.gov. Search by Funding Opportunity Number: RFA–FD–14–017. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For all electronically submitted applications, the following steps are required. • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With System for Award Management (SAM) • Step 3: Obtain Username & Password • Step 4: Authorized Organization Representative (AOR) Authorization • Step 5: Track AOR Status • Step 6: Register With Electronic Research Administration (eRA) Commons mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2011–D–0835] HHS. The scope of the proposed project should determine the project period. The maximum project period is 5 years. Steps 1 through 5, in detail, can be found at https://www07.grants.gov/ applicants/organization_ registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/ commons/registration/ registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: https:// www.grants.gov. Dated: May 15, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11924 Filed 5–22–14; 8:45 am] BILLING CODE 4160–01–P 18:44 May 22, 2014 Food and Drug Administration AGENCY: B. Length of Support VerDate Mar<15>2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 232001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 29781 Submit written comments to the Division of Dockets Managements (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Bridget Foltz, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5174, Silver Spring, MD 20993, 301–796–8340. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled, ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.’’ The guidance discusses the regulatory responsibilities of IRBs, clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. In particular, the guidance discusses eight steps to be considered when transferring oversight of a previously approved clinical investigation from one IRB to another IRB. These include identifying those studies for which IRB oversight is being transferred; ensuring availability and retention of pertinent records; establishing an effective date for the transfer of oversight; conducting a review of the study(ies) by the receiving IRB, where appropriate; confirming or establishing the date for the next continuing review; determining whether the consent form needs to be revised; notifying the key parties; and updating IRB registration information. The IRB transfer process is expected to vary depending on the reasons for the transfer, the parties involved, and the number and risk of the studies being transferred. To enhance human subject protections and reduce regulatory burden, FDA and the Office for Human Research Protections (OHRP) have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research. This guidance document was developed as a part of these efforts and in consultation with OHRP. In the Federal Register of June 12, 2012 (77 FR 34958), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and considered them in preparing the final guidance. In response to the comments, FDA added a recommendation that the receiving IRB notify the sponsor if it decides to suspend or terminate study E:\FR\FM\23MYN1.SGM 23MYN1 29782 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices approval. FDA also clarified both drug and device sponsor’s reporting requirements related to such suspensions and terminations. Section III(6) was modified to recommend the use of a letter to provide currently enrolled subjects with any changes in contact information regarding subject rights or research-related injuries from a resulting IRB transfer. In addition, numerous editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated June 2012. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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 guidance refers to previously 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 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; and the collections of information in 21 CFR part 56 have been approved under OMB control number 0910–0130. mstockstill on DSK4VPTVN1PROD with NOTICES III. Comments Interested persons may submit either electronic comments regarding this document 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.regulations.gov or https:// www.fda.gov/ScienceResearch/ SpecialTopics/RunningClinicalTrials/ ProposedRegulationsandDraft Guidances/default.htm. VerDate Mar<15>2010 18:44 May 22, 2014 Jkt 232001 Dated: May 15, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11923 Filed 5–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–E–0469] Determination of Regulatory Review Period for Purposes of Patent Extension; LINZESS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for LINZESS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions (two copies are required) and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to https:// www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993–0002, 301–796–7900. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product LINZESS (linaclotide). LINZESS is indicated for treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for LINZESS (U.S. Patent No. 7,304,036) from Ironwood Pharmaceuticals, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 10, 2013, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of LINZESS represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for LINZESS is 2,863 days. Of this time, 2,475 days occurred during the testing phase of the regulatory review period, while 388 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: October 30, 2004. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 30, 2004. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 9, 2011. FDA has verified the applicant’s claim E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29781-29782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11923]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0835]


Guidance for Institutional Review Boards, Clinical Investigators, 
and Sponsors: Considerations When Transferring Clinical Investigation 
Oversight to Another Institutional Review Board; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for IRBs, Clinical 
Investigators, and Sponsors: Considerations When Transferring Clinical 
Investigation Oversight to Another IRB.'' The guidance announced in 
this document discusses regulatory responsibilities of institutional 
review boards (IRBs), clinical investigators, and sponsors when 
oversight of a previously approved clinical investigation under FDA's 
jurisdiction is transferred from one IRB to another IRB. The guidance 
also addresses questions that have been previously raised concerning 
procedures and processes that are required and/or recommended by FDA 
when such oversight is transferred.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Managements (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bridget Foltz, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 5174, Silver Spring, MD 20993, 301-796-8340.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled, 
``Guidance for IRBs, Clinical Investigators, and Sponsors: 
Considerations When Transferring Clinical Investigation Oversight to 
Another IRB.'' The guidance discusses the regulatory responsibilities 
of IRBs, clinical investigators, and sponsors when oversight of a 
previously approved clinical investigation under FDA's jurisdiction is 
transferred from one IRB to another IRB. In particular, the guidance 
discusses eight steps to be considered when transferring oversight of a 
previously approved clinical investigation from one IRB to another IRB. 
These include identifying those studies for which IRB oversight is 
being transferred; ensuring availability and retention of pertinent 
records; establishing an effective date for the transfer of oversight; 
conducting a review of the study(ies) by the receiving IRB, where 
appropriate; confirming or establishing the date for the next 
continuing review; determining whether the consent form needs to be 
revised; notifying the key parties; and updating IRB registration 
information. The IRB transfer process is expected to vary depending on 
the reasons for the transfer, the parties involved, and the number and 
risk of the studies being transferred.
    To enhance human subject protections and reduce regulatory burden, 
FDA and the Office for Human Research Protections (OHRP) have been 
actively working to harmonize the agencies' regulatory requirements and 
guidance for human subjects research. This guidance document was 
developed as a part of these efforts and in consultation with OHRP.
    In the Federal Register of June 12, 2012 (77 FR 34958), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and considered them in 
preparing the final guidance. In response to the comments, FDA added a 
recommendation that the receiving IRB notify the sponsor if it decides 
to suspend or terminate study

[[Page 29782]]

approval. FDA also clarified both drug and device sponsor's reporting 
requirements related to such suspensions and terminations. Section 
III(6) was modified to recommend the use of a letter to provide 
currently enrolled subjects with any changes in contact information 
regarding subject rights or research-related injuries from a resulting 
IRB transfer. In addition, numerous editorial changes were made to 
improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated June 2012.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance refers to previously 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 312 have been approved under 
OMB control number 0910-0014; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 56 have been approved under 
OMB control number 0910-0130.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document 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.

IV. Electronic Access

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

    Dated: May 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11923 Filed 5-22-14; 8:45 am]
BILLING CODE 4160-01-P
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