Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution, 34949-34950 [2012-14287]

Download as PDF Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices substantial service in their license area within 10 years of being licensed. Section 101.529 requires that in order to receive a renewal expectancy at renewal time, a 24 GHz licensee must demonstrate that it provided substantial service. 24 GHz licensees must also provide copies of all FCC orders finding the licensee to have violated the Communications Act or any FCC rule or policy, and a list of any pending proceeding relating to any such possible violation. Section 101.103 requires that LMDS licensees coordinate proposed operations with existing licensees, permittees, and applicants in the proposed area of operation. Coordination consists of notification by the licensee of its proposed operations, and a response by neighboring licensees, permittees, and applicants stating whether any interference is predicted. The coordination requirements set forth in the Commission’s rules remains unchanged, and this submission does not seek to revise those requirements or the estimated burdens relating to that rule. Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary, Office of Managing Director. [FR Doc. 2012–14230 Filed 6–11–12; 8:45 am] BILLING CODE 6712–01–P FEDERAL COMMUNICATIONS COMMISSION Information Collection Being Reviewed by the Federal Communications Commission Federal Communications Commission. ACTION: Notice and request for comments. AGENCY: As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44.U.S.C. 3501– 3520), the Federal Communications Commission (FCC) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission’s burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number. DATES: Written PRA comments should be submitted on or before August 13, 2012. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to Cathy Williams, FCC, via email PRA@fcc.gov and to Cathy.Williams@fcc.gov. For additional information about the information collection, contact Cathy Williams at (202) 418–2918. OMB Control Number: 3060–0580. Title: Section 76.1710, Operator Interests in Video Programming. Form Number: N/A. Type of Review: Extension of a currently approved collection. Respondents: Business or other forprofit entities. Number of Respondents and Responses: 1,500 respondents; 1,500 responses. Estimated Time per Response: 15 hours. Frequency of Response: Recordkeeping requirement. Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 Section 154(i) of the Communications Act of 1934, as amended. Total Annual Burden: 22,500 hours. Total Annual Costs: None. Privacy Impact Assessment(s): No impact(s). Nature and Extent of Confidentiality: There is no need for confidentiality and respondents are not being asked to submit confidential information to the Commission. Needs and Uses: 47 CFR 76.1710 requires cable operators to maintain records in their public file for a period of three years regarding the nature and extent of their attributable interests in all video programming services. The FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 34949 records must be made available to members of the public, local franchising authorities and the Commission on reasonable notice and during regular business hours. The records will be reviewed by local franchising authorities and the Commission to monitor compliance with channel occupancy limits in respective local franchise areas. Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary, Office of Managing Director. [FR Doc. 2012–14177 Filed 6–11–12; 8:45 am] BILLING CODE 6712–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health, Office for Human Research Protections. ACTION: Notice. AGENCY: The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled ‘‘Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution,’’ and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP’s first formal guidance on this topic. The draft document, which is available on the OHRP Web site at https://www.hhs.gov/ ohrp/newsroom/rfc/, is intended primarily for institutional review boards (IRB), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document. DATES: Submit written comments by August 13, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution’’ to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, SUMMARY: E:\FR\FM\12JNN1.SGM 12JNN1 34950 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices Rockville, MD 20852. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 301–402–2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document. You may submit comments identified by docket ID number HHS–OS–OPHS– 2012–0005, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Enter the above docket ID number in the ‘‘Enter Keyword or ID field and click on ‘‘Search.’’ On the next page, click the ‘‘Submit a Comment’’ action and follow the instructions. • Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions]: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240–453–6900; email Irene.Stith-Coleman@hhs.gov. SUPPLEMENTARY INFORMATION: I. Background srobinson on DSK4SPTVN1PROD with NOTICES A. Overview OHRP, Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled ‘‘Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution.’’ The draft guidance document, when finalized, will represent OHRP’s current thinking on this topic and will provide OHRP’s first formal guidance on this topic. The draft document is intended primarily for IRBs, institutions, and investigators that may be responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. The guidance document would apply to non-exempt human subjects research conducted or supported by HHS. It presents common scenarios for transfer of a previously-approved research project to another institutional review board (IRB) or to a new engaged research institution, and outlines the administrative actions to be considered by IRBs, engaged institution(s), and investigators. In particular, the guidance addresses the following questions: VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 1. What is the regulatory background for research project transfer? 2. What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred either from an internal to an external IRB, or from an external IRB to another external IRB? 3. What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred from one internal to another internal IRB? 4. What actions may apply when the research project is transferred to a new engaged institution? To enhance human subject protections and reduce regulatory burden, OHRP and the Food and Drug Administration (FDA) have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research. FDA has simultaneously published in this same issue of the Federal Register a draft guidance document entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors, Considerations When Transferring Clinical Investigation Oversight to Another IRB’’ that is similar to OHRP’s draft document. FDA and OHRP recognize that the two documents may appear somewhat different as there are minor variations in formatting and some necessary variations due to differences in the regulated entities under FDA’s and OHRP’s jurisdiction. The agencies wish to stress, however, that our intent was to provide harmonized guidance to IRBs, sponsors, institutions, investigators, and other entities involved in the study oversight transfer process. FDA and OHRP will continue to work closely in the development of final guidance and appreciate comments from interested parties. II. Electronic Access Persons with access to the Internet may obtain the draft guidance document on OHRP’s Web site at https:// www.hhs.gov/ohrp/newsroom/rfc/ index.html or on the Federal eRulemaking Portal at https:// www.regulations.gov/. Dated: June 7, 2012. Ivor Pritchard, Senior Advisor to the Director, Office for Human Research Protections. [FR Doc. 2012–14287 Filed 6–11–12; 8:45 am] BILLING CODE 4150–36–P PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Decision To Evaluate a Petition To Designate a Class of Employees From the Clarksville Facility in Clarksville, TN, To Be Included in the Special Exposure Cohort National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services. ACTION: Notice. AGENCY: NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Clarksville Facility in Clarksville, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Clarksville Facility. Location: Clarksville, Tennessee. Job Titles and/or Job Duties: Workers potentially exposed to radioactive materials while working at the Clarksville facility. Period of Employment: January 1, 1949 to December 31, 1967. FOR FURTHER INFORMATION CONTACT: Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 877–222–7570. Information requests can also be submitted by email to DCAS@CDC.GOV. SUMMARY: John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2012–14221 Filed 6–11–12; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Decision To Evaluate a Petition To Designate a Class of Employees From the Medina Facility in San Antonio, TX, To Be Included in the Special Exposure Cohort National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services. ACTION: Notice. AGENCY: E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34949-34950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14287]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Draft Guidance on Considerations in Transferring a Previously-
Approved Research Project to a New IRB or Research Institution

AGENCY: Department of Health and Human Services (HHS), Office of the 
Secretary, Office of the Assistant Secretary for Health, Office for 
Human Research Protections.

ACTION: Notice.

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

SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health, is announcing the availability of a 
draft guidance document entitled ``Draft Guidance on Considerations in 
Transferring a Previously-Approved Research Project to a New IRB or 
Research Institution,'' and is seeking comment on the draft guidance. 
The draft guidance document, when finalized, would provide OHRP's first 
formal guidance on this topic. The draft document, which is available 
on the OHRP Web site at https://www.hhs.gov/ohrp/newsroom/rfc/, is intended primarily for institutional review boards 
(IRB), institutions, and investigators that are responsible for the 
review, conduct, or oversight of human subjects research conducted or 
supported by HHS. OHRP will consider comments received before issuing 
the final guidance document.

DATES: Submit written comments by August 13, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance on Considerations in 
Transferring a Previously-Approved Research Project to a New IRB or 
Research Institution'' to the Division of Policy and Assurances, Office 
for Human Research Protections, 1101 Wootton Parkway, Suite 200,

[[Page 34950]]

Rockville, MD 20852. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-402-
2071. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance document.
    You may submit comments identified by docket ID number HHS-OS-OPHS-
2012-0005, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Enter the above docket ID number in the ``Enter Keyword or ID field and 
click on ``Search.'' On the next page, click the ``Submit a Comment'' 
action and follow the instructions.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Irene Stith-Coleman, Ph.D., Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received, including any personal information, will be posted 
without change to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for 
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
MD 20852, 240-453-6900; email Irene.Stith-Coleman@hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Overview

    OHRP, Office of the Assistant Secretary for Health, is announcing 
the availability of a draft guidance document entitled ``Draft Guidance 
on Considerations in Transferring a Previously-Approved Research 
Project to a New IRB or Research Institution.'' The draft guidance 
document, when finalized, will represent OHRP's current thinking on 
this topic and will provide OHRP's first formal guidance on this topic. 
The draft document is intended primarily for IRBs, institutions, and 
investigators that may be responsible for the review, conduct, or 
oversight of human subjects research conducted or supported by HHS.
    The guidance document would apply to non-exempt human subjects 
research conducted or supported by HHS. It presents common scenarios 
for transfer of a previously-approved research project to another 
institutional review board (IRB) or to a new engaged research 
institution, and outlines the administrative actions to be considered 
by IRBs, engaged institution(s), and investigators. In particular, the 
guidance addresses the following questions:
    1. What is the regulatory background for research project transfer?
    2. What actions may apply when the research project remains at the 
same institution, but responsibility for IRB review is transferred 
either from an internal to an external IRB, or from an external IRB to 
another external IRB?
    3. What actions may apply when the research project remains at the 
same institution, but responsibility for IRB review is transferred from 
one internal to another internal IRB?
    4. What actions may apply when the research project is transferred 
to a new engaged institution?

To enhance human subject protections and reduce regulatory burden, OHRP 
and the Food and Drug Administration (FDA) have been actively working 
to harmonize the agencies' regulatory requirements and guidance for 
human subjects research.
    FDA has simultaneously published in this same issue of the Federal 
Register a draft guidance document entitled ``Guidance for IRBs, 
Clinical Investigators, and Sponsors, Considerations When Transferring 
Clinical Investigation Oversight to Another IRB'' that is similar to 
OHRP's draft document.
    FDA and OHRP recognize that the two documents may appear somewhat 
different as there are minor variations in formatting and some 
necessary variations due to differences in the regulated entities under 
FDA's and OHRP's jurisdiction. The agencies wish to stress, however, 
that our intent was to provide harmonized guidance to IRBs, sponsors, 
institutions, investigators, and other entities involved in the study 
oversight transfer process. FDA and OHRP will continue to work closely 
in the development of final guidance and appreciate comments from 
interested parties.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document on OHRP's Web site at https://www.hhs.gov/ohrp/newsroom/rfc/ or on the Federal eRulemaking Portal at https://www.regulations.gov/.

    Dated: June 7, 2012.
Ivor Pritchard,
Senior Advisor to the Director, Office for Human Research Protections.
[FR Doc. 2012-14287 Filed 6-11-12; 8:45 am]
BILLING CODE 4150-36-P

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