        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        45 CFR Part 46
        Office for Human Research Protections; Institutional Review Boards

          AGENCY:
          Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office for Human Research Protections.

          ACTION:
          Advanced notice of proposed rulemaking; request for comments.

          SUMMARY:
          The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments on whether OHRP should pursue a notice of proposed rulemaking (NPRM) to enable OHRP to hold institutional review boards (IRB) and the institutions or organizations operating the IRBs, hereafter referred to as the IRB organizations (IORG), directly accountable for meeting certain regulatory requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects. OHRP is contemplating this regulatory change to encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate. Historically, OHRP has only enforced compliance with 45 CFR part 46 through the institutions that were engaged in human subjects research. This has been the case even in circumstances when a regulatory violation was directly related to the responsibilities of an external IRB that was designated on the engaged institution's assurance of compliance with OHRP. OHRP is considering whether to pursue a regulatory change that would enable the Department to hold IRBs and IORGs directly accountable for compliance with the provisions of 45 CFR part 46 that relate to an IRB's or IORG's responsibilities. OHRP believes that such a regulatory change in its enforcement authority may address one of the main disincentives institutions have cited as inhibiting them from exercising the regulatory flexibility that currently permits institutions to implement a variety of cooperative review arrangements and to rely on the review of an IRB operated by another institution or organization. If institutions become more willing to rely on cooperative review arrangements and on review of IRBs operated by other institutions or organizations, OHRP believes that this will reduce administrative burdens such as the time associated with IRB review for multi-site studies, the time devoted by IRB staff and investigators to duplicative IRB review, and the time and personnel costs associated with operating an IRB for those institutions that choose not to establish an internal IRB—without diminishing human subject protections. This request for information and comments stems from interest in this issue from the Secretary's Advisory Committee on Human Research Protections (SACHRP) and others, as well as two meetings on alternative IRB models that OHRP co-sponsored in November 2005 and November 2006 along with the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC), and the American Society of Clinical Oncology (ASCO).

          DATES:
          Submit written or electronic information and comments by June 3, 2009.

          ADDRESSES:
          You may submit comments by any of the following methods:
          • E-mail: IRBaccountability@hhs.gov. Include “IRB Accountability RFI” in the subject line.
          • Fax: 301-402-2071.
          • Mail/Hand Delivery/Courier [For paper, disk, or CD-ROM submissions]: Julie Kaneshiro, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
          Comments received within the comment period, including any personal information provided, will be made available to the public upon request.

          FOR FURTHER INFORMATION CONTACT:

          Julie Kaneshiro, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; 240-453-6900; e-mail julie.kaneshiro@hhs.gov.

        SUPPLEMENTARY INFORMATION:
        I. Background
        HHS, through OHRP, regulates research involving human subjects conducted or supported by HHS in regulations codified at 45 CFR part 46. The HHS regulations at 45 CFR part 46 identify requirements that pertain to several different entities, including the IRB and the institution engaged in non-exempt human subjects research. The IRB is an administrative body that takes the form of a board, committee, or group, and is responsible for conducting initial and continuing review of research involving human subjects. The IRB must have authority to approve, require modification in (in order to secure approval), or disapprove all research activities covered by the HHS regulations (45 CFR 46.109(a)). An IRB's primary purpose in reviewing research is to ensure the protection of the rights and welfare of human research subjects.
        Requirements for an Assurance of Compliance

        The HHS regulations for the protection of human subjects require that each institution engaged in non-exempt human subjects research conducted or supported by HHS provide a written assurance satisfactory to the Secretary of Health and Human Services that it will comply with the requirements of the HHS regulations (45 CFR 46.103(a)). OHRP reviews and approves such assurances on behalf of HHS. The Federalwide Assurance (FWA) is now the only type of assurance accepted and approved by OHRP. An FWA commits the entire institution (including institutional officials, IRBs designated in the assurance, research investigators, and all other employees or agents) to compliance with the HHS regulations whenever the institution is engaged in HHS-conducted or -supported human subjects research. In addition, domestic institutions may voluntarily extend their FWA to cover all human subjects research at their institution regardless of the source of support for the particular research activity.
        Among other things, an institution's assurance of compliance must designate all of the IRBs that the institution will rely upon for the review of any research covered by its assurance (45 CFR 46.103(b)(2)). For each designated IRB, a list of IRB members identified by name, earned degrees, representative capacity, experience, and any employment or other relationship with the institution must be submitted to OHRP (45 CFR 46.103(b)(3)). The HHS regulations at 45 CFR part 46 provide an institution with significant flexibility in designating the IRBs that will review research under the institution's FWA. Options available to the institution include:
        • Designating on its FWA one or more IRBs that are operated by the institution (sometimes referred to as “local” or “internal” IRBs; hereafter referred to as “internal IRBs”); and
        • Designating on its FWA one or more IRBs operated by other institutions or commercial or independent IRBs (hereafter referred to as “external IRBs”).
        As stated in the Terms of Assurance for the FWA (see http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm), for each external IRB designated on an institution's FWA, an IRB Authorization Agreement must be executed:

          Any designation under this Assurance of another Institution's IRB or an independent IRB must be documented by a written agreement between the Institution and the IRB organization outlining their relationship and include a commitment that the designated IRB will adhere to the requirements of this Assurance. OHRP's sample IRB Authorization Agreement may be used for such purpose or the two organizations may develop their own agreement. This agreement should be kept on file at both organizations and made available to OHRP upon request.

        OHRP provides an example of an IRB Authorization Agreement at http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf. The agreement may be written to cover one research project, or to cover multiple research projects on a case-by-case basis, or to cover a class of research projects. This agreement will sometimes include a description of which regulatory requirements each party will be responsible for; e.g., reporting unanticipated problems involving risks to subjects or others (45 CFR 46.103(b)(5)) or the maintenance of IRB records (45 CFR 46.115).
        Requirements for IRB Registration

        Before an IRB may be designated on an institution's FWA, the IRB must be registered with OHRP. For more information on IRB registration see http://www.hhs.gov/ohrp/assurances/.
        OHRP has been operating a system of IRB registration since December 2000, which was initiated in response to a 1998 HHS Office of Inspector General recommendation that all IRBs register with the Federal government on a regular basis as part of an effort to develop a more streamlined, coordinated, and probing means of assessing IRB performance and to enhance the Federal government's ability to identify and respond to emerging problems.
        The OHRP IRB registration system was designed to collect information required under the HHS human subjects protection regulations at 45 CFR 46.103, as well as additional information that is provided voluntarily by institutions or IRBs regarding the accreditation status of the institution or IRB organization, the total numbers of active research protocols reviewed by the IRB (including protocols supported by other Federal departments or agencies) and the nature of those protocols, and IRB staffing.
        On July 6, 2004, OHRP published in the Federal Register a Notice of Proposed Rulemaking (NPRM) seeking public comment on changes to the current IRB registration system administered by OHRP (69 FR 40584). OHRP proposed to amend the HHS human subjects protection regulations at 45 CFR part 46 by adding an additional subpart, entitled “Registration of Institutional Review Boards.” Under the proposed new subpart, for any IRB designated under an FWA that reviews human subjects research conducted or supported by HHS, most of the information, including the information that previously was provided on a voluntary basis, listed on the current OHRP IRB registration form would have to be submitted to OHRP. By requiring such information to be provided for all IRBs being registered, OHRP's IRB registration requirements would become substantially consistent with requirements for IRB registration that were simultaneously proposed by FDA (69 FR 40556).
        After taking into consideration the comments received during the public comment period, OHRP and FDA issued separate final IRB registration rules on January 15, 2009, that will become effective on July 14, 2009 (74 FR 2399; 74 FR 2358). OHRP's and FDA's IRB registration rules are compatible and largely consistent with one another. Under these final rules there will be a single registration system, accessible on the OHRP Web site, in which all IRBs that review research conducted or supported by HHS or clinical investigations regulated by FDA will need to be registered.
        Enforcement Authority
        Section 289 of the Public Health Service Act authorizes OHRP to, on behalf of HHS, establish a compliance oversight process regarding violations of the rights of human subjects of research conducted or supported by HHS. Pursuant to this authority, OHRP may receive reports of such violations and take appropriate action.
        OHRP also derives compliance oversight authority from the previously discussed provisions of the HHS regulations at 45 CFR 46.103(a) and its implementation of the FWA.
        Unlike the FDA regulations pertaining to IRBs, which explicitly include compliance oversight provisions at subpart E of 21 CFR part 56, the HHS regulations at 45 CFR part 46 do not include provisions specifically addressing IRB or IORG compliance with the regulatory requirements.
        II. History of OHRP Compliance Oversight and the Changing Research Environment

        Historically, OHRP (and its predecessor office, the Office for Protection from Research Risks) has only enforced compliance with 45 CFR part 46 through the institutions that were engaged in human subjects research. This has been the case even in circumstances when the regulatory violation was directly related to the responsibilities of an external IRB that was designated on the engaged institution's assurance of compliance with OHRP. Therefore, when OHRP received an allegation or indication of a regulatory violation on the part of an external IRB related to research to which the HHS regulations apply, OHRP has directed its compliance oversight evaluations and enforcement actions to the relevant FWA-holding institutions, not the external IRB or IORG at issue. When the HHS regulations related to IRB review last underwent a substantive revision on June 18, 1991 (56 FR 28003), few institutions were designating external IRBs to review research conducted under their assurances of compliance, in part because single site studies were more common than they are today, and it was more common for HHS-supported research to be conducted by large academic medical centers that had their own internal IRBs. Therefore, there was no perceived need to hold IRBs or IORGs directly accountable for meeting any of the requirements of the HHS regulations at 45 CFR part 46. However, as HHS support for multi-site studies has increased, and previously non-traditional research settings, such as community hospitals and medical clinics, have become frequent research sites, the research community has looked for ways to make IRB review more effective and efficient.
        III. Current Regulatory Flexibilities for IRB Review Arrangements

        The regulations offer institutions significant flexibility to implement a variety of cooperative review arrangements as permitted under 45 CFR 46.114. In addition, this flexibility is facilitated by the ability of institutions to designate external IRBs on their FWAs that will be responsible for the review of one or more research studies in which the institution will be engaged. These regulatory flexibilities are intended to reduce administrative burden without diminishing human subject protections. For example, two or more institutions engaged in the same multi-center research project can designate the same IRB (e.g., an IRB operated by one of the institutions engaged in the project) on their FWAs to review that research project. Similarly, institutions that do not have an internal IRB (for example, because they conduct little human subjects research) may designate an external IRB on their FWAs to review one or more research studies. Another IRB review model permitted under 45 CFR part 46 is for an institution to designate more than one IRB on its FWA to share authority and responsibility for the review of certain research studies. For example, the facilitated review model developed by the National Cancer Institute utilizes a central IRB, as well as review by another IRB—typically an internal IRB operated by the institution engaged in the research—that is responsible for considering issues related to the local context in which the research will be conducted. These regulatory flexibilities under 45 CFR part 46, that permit institutions to implement a variety of IRB review arrangements, are intended to reduce administrative burdens such as the time associated with IRB review for multi-site studies, the time devoted by IRB staff and investigators to duplicative IRB review, and the time and personnel costs associated with operating an IRB for those institutions that choose not to establish an internal IRB.
        Despite the regulatory flexibility to implement a wide range of IRB review arrangements, OHRP has become aware that some institutions remain reluctant to designate external IRBs on their FWAs and/or rely upon cooperative IRB review arrangements.
        IV. OHRP Co-Sponsored Meetings on Alternative IRB Models

        OHRP's practice of holding an institution engaged in a human subjects research study accountable for noncompliance on the part of an external IRB that was designated on the institution's FWA and was responsible for reviewing the research was identified as one of the key factors influencing institutions' decisions about this issue by participants in two meetings on alternative IRB models that OHRP co-sponsored in November 2005 and November 2006. OHRP co-sponsored these meetings along with NIH, AAMC, and ASCO, in response to a suggestion made by SACHRP in the fall of 2004 that OHRP further explore issues associated with the use of alternatives to local IRBs. Reports summarizing the findings of these two meetings can be found at http://www.dhhs.gov/ohrp/sachrp/documents/AltModIRB.pdf and http://www.aamc.org/research/irbreview/irbconf06rpt.pdf. Participants in the 2005 and 2006 meetings included individuals from a variety of perspectives, including IRB chairs, academic investigators, community-based researchers, attorneys, patients, ethicists, industry officials and senior university and medical school research administrators. While other factors were also identified as contributing to institutions' reluctance to adopt alternatives to the internal IRB review model, it is OHRP's understanding from participants in this meeting, as well as others in the community, that concerns related to regulatory liability are a significant consideration. Namely, one of the main factors identified as contributing to institutions' reluctance to rely on an external IRB is OHRP's current practice of enforcing compliance with 45 CFR part 46 through the institutions that were engaged in human subjects research, even in circumstances when the regulatory violation is directly related to the responsibilities of an external IRB. Given this, OHRP believes that expanding its enforcement authority to include IRBs and IORGs directly may make institutions more likely to designate external IRBs on their FWAs and/or enter into cooperative IRB review arrangements.
        V. Possible Administrative Actions for Noncompliance by IRBs or IORGs
        If HHS were to implement a regulation that would enable OHRP to hold IRBs and IORGs directly accountable for meeting certain regulatory requirements of 45 CFR part 46, OHRP envisions that it would generally only exercise this regulatory option when the IRB at issue was external to the institution engaged in the human subjects research, and was designated on the institution's FWA to review the research. In circumstances when the IRB at issue was internal to the institution engaged in the human subjects research, OHRP expects that it would continue to enforce compliance with 45 CFR part 46 through the engaged institution.
        However, when the possible regulatory noncompliance at issue was the responsibility of an IRB external to the institution engaged in the human subjects research, and the external IRB was designated on the institution's FWA to review the research, OHRP generally would expect to enforce compliance with 45 CFR part 46 directly with the external IRB, and not the FWA-holding institution. OHRP contemplates a number of administrative actions that HHS could take in response to a finding of noncompliance with 45 CFR part 46 by an external IRB designated on an institution's FWA. Depending on the nature and scope of the IRB's or IORG's noncompliance, OHRP could, for example, require that the IRB or IORG implement certain corrective actions, restrict or impose conditions on the IRB's registration with OHRP, or suspend the IRB's registration with OHRP which would prohibit the IRB from being designated on any institution's FWA.
        VI. Identifying Responsibilities of the IRB/IORG and FWA-Holding Institution

        In considering how HHS would implement a regulation that would enable OHRP to hold IRBs and IORGs directly accountable for meeting certain regulatory requirements of 45 CFR part 46, OHRP has begun the process of identifying which entities might be responsible for fulfilling the various regulatory requirements. Some of the regulatory requirements seem to fall uniquely to either the IRB/IORG or the FWA-holding institution, and others seem to be requirements that could be carried out by either the IRB/IORG or the FWA-holding institution. OHRP envisions that some form of agreement between the IRB/IORG and the FWA-holding institution would determine which entity would be responsible for fulfilling the regulatory requirements that could be carried out by either the IRB/IORG or the FWA-holding institution. In an attempt to facilitate public comment on this request for information regarding IRB accountability, OHRP has made a preliminary attempt to group the regulatory requirements into the following three categories: (1) Responsibilities that may be unique to IRBs and IORGs; (2) responsibilities that may be unique to institutions engaged in human subjects research; and (3) responsibilities that may be fulfilled by either IRBs/IORGs or institutions engaged in human subjects research.
        OHRP considered whether there are any regulatory requirements that are inherently shared by both the IRB/IORG and the FWA-holding institution, but did not identify any requirements that seemed to fall into this category. Section VII of this notice includes a question that specifically seeks public comment on this issue.
        The categorization below is in no way intended to be definitive or complete, but rather a basis for public comment.
        Responsibilities That May Be Unique to IRBs and IORGs
        • The provisions regarding IRB membership and qualifications necessary to promote complete and adequate review of the human subjects research conducted by the institution for which the IRB was designated on an institution's assurance of compliance with OHRP (§ 46.107).
        • The provision that the IRB follow written procedures in the same detail as described in 45 CFR 46.103(b)(4) and to the extent required by 45 CFR 46.103(b)(5) (§ 108(a)).
        • The provision that except when an expedited review procedure is used (see § 46.110), the IRB review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting (§ 46.108(b)).
        • The provision that an IRB shall review and approve, require modifications in (to secure approval), or disapprove all research activities covered by 45 CFR part 46, for which the IRB was designated on an institution's assurance of compliance with OHRP (§ 46.109(a)).
        • The provision that an IRB shall require that information given to subjects as part of informed consent is in accordance with § 46.116. The IRB may require that information, in addition to that specifically mentioned in § 46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects (§ 46.109(b)).
        • The provision that an IRB shall require documentation of informed consent or may waive documentation in accordance with § 46.117 (§ 46.109(c)).
        • The provision that an IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing (§ 46.109(d)).
        • The provision that an IRB shall conduct continuing review of research covered by 45 CFR part 46, at intervals appropriate to the degree of risk, but not less than once per year (§ 46.109(e)).
        • The provision related to expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research (§ 46.110).
        • The provision that identifies the criteria for IRB approval of research (§ 46.111).
        • The provisions that permit an IRB to approve a consent procedure which does not include, or which alters some or all of the elements of informed consent set forth in § 46.116, or waive the requirements to obtain informed consent provided the IRB finds and documents that specified criteria have been met (§ 46.116(c) and (d)).
        • The provisions that require informed consent to be documented by use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, unless the IRB finds that specified criteria permitting the waiver of documentation of informed consent have been met (§ 46.117).
        Responsibilities That May Be Unique to Institutions Engaged in Human Subjects Research
        • The provision that institutions engaged in HHS-supported human subjects research must submit an FWA to OHRP for approval and comply with the requirements imposed as part of the FWA, including among other things, the designation of one or more IRBs on the institution's FWA that have been registered with OHRP (§ 46.103).
        • The requirement that before implementing a change to an IRB-approved research study, an investigator must obtain IRB approval for the change, unless the change is designed to eliminate an apparent immediate hazard to subjects (§ 46.103(b)(4)).
        • The requirement that an investigator must obtain continuing IRB review of ongoing non-exempt human subjects research prior to the expiration date of the current IRB approval (§ 46.103(b)(4)).
        • The requirement for the prompt reporting to the IRB of any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with 45 CFR part 46 or the requirements or determinations of the IRB (§ 46.103(b)(5)).
        • The requirement that an investigator must obtain IRB review and approval before beginning any non-exempt human subjects research (§ 46.109(a)).
        • The provision that the IRB must have authority to approve, require modifications in (to secure approval), or disapprove all research activities for which the IRB was designated on an institution's assurance of compliance with OHRP (§ 46.109(a)).
        • The provision that the IRB must have authority to observe or have a third party observe the consent process and the research for all research activities for which the IRB was designated on an institution's assurance of compliance with OHRP (§ 46.109(e)).
        • The provision that research covered by 45 CFR part 46 that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, these officials may not approve the research if it has not been approved by an IRB (§ 46.112).
        • The provision that the IRB must have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects for all research activities for which the IRB was designated on an institution's assurance of compliance with OHRP (§ 46.113).
        • The requirement that except as provided elsewhere in 45 CFR part 46 no investigator may involve a human being as a subject in research covered by 45 CFR part 46 unless the investigator has obtained and documented the legally effective informed consent of the subject or the subject's legally authorized representative (§ 46.116 and § 46.117).

        • The requirement that investigators give a copy of the informed consent document to each research subject or the subject's legally authorized representative, and keep the signed original or a copy of it for their records, unless the IRB finds that specified criteria permitting the waiver of documentation of informed consent have been met (§ 46.117; § 46.115(b)).
        Responsibilities That May Be Fulfilled by Either IRBs/IORGs or Institutions Engaged in Human Subjects Research

        • Determining the applicability of the HHS regulations at 45 CFR part 46 (e.g., the exemptions at 46.101(b)).
        • Developing written IRB procedures which the IRB will follow:
        (1) For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
        (2) For determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and
        (3) For ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject (§ 46.103(b)(4)).
        • Developing written IRB procedures for ensuring the prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head of:
        (1) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with 45 CFR part 46 or the requirements or determinations of the IRB; and
        (2) Any suspension or termination of IRB approval (§ 46.103(b)(5).
        • Promptly reporting to the appropriate institutional officials and the Department or Agency head:
        (1) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with 45 CFR part 46 or the requirements or determinations of the IRB; and
        (2) Any suspension or termination of IRB approval, including a statement of the reasons for the IRB's actions (§ 46.103(b)(5); § 46.113).
        • Promptly reporting to the investigator any suspension or termination of approval by the IRB, including a statement of the reasons for the IRB's actions (§ 46.113).
        • Fulfilling the documentation and recordkeeping requirements associated with IRB activities (§ 46.115).
        VII. Request for Information and Comments
        OHRP is seeking information and comments from the public about whether OHRP should pursue an NPRM to enable OHRP to hold IRBs and IORGs directly accountable for meeting certain regulatory requirements of the HHS regulations for the protection of human subjects at 45 CFR part 46. OHRP specifically seeks information and comments on the following issues; comments should also include a reference to the specific numbered question being addressed:
        1. Is there sufficient need for HHS to pursue a regulatory change to enable OHRP to hold IRBs and IORGs directly accountable for meeting certain requirements of the HHS regulations at 45 CFR part 46? Please explain your response.
        2. Would the proposed regulatory change reduce concerns about regulatory liability as a barrier to the use of external IRBs and contribute to an increase in collaborative IRB review arrangements?
        3. Are there other approaches and strategies that would decrease concern about regulatory liability and increase collaborative IRB review arrangements?
        4. If HHS were to issue a regulation that would enable OHRP to hold IRBs and IORGs directly accountable for meeting certain requirements of the HHS regulations at 45 CFR part 46, would this have the unintended effect of making institutions or IORGs less willing to have their IRBs designated as external IRBs on other institutions' FWAs? If so, would there still be sufficient benefit for HHS to pursue a regulatory change to enable OHRP to hold IRBs and IORGs directly accountable for meeting certain requirements of the HHS regulations? Are there other possible unintended effects of the proposed regulatory change? Please explain your responses.

        5. If HHS pursues a regulatory change to enable OHRP to hold IRBs and IORGs directly accountable for meeting certain requirements of the HHS regulations at 45 CFR part 46, what kinds of administrative actions would be appropriate for OHRP to take against IRBs that are found to be out of compliance with 45 CFR part 46? For a description of some of the corrective actions that OHRP has required when it has been determined that an institution was not in compliance with 45 CFR part 46, see OHRP's guidance document entitled, “OHRP's Compliance Oversight Procedures for Evaluating Institutions” at http://www.dhhs.gov/ohrp/compliance/ohrpcomp.pdf.
        6. As described in Section VI of this notice, in order to facilitate public comment, OHRP has made a preliminary attempt to group some of the regulatory requirements under 45 CFR part 46 into the following three categories: (1) Responsibilities that may be unique to IRBs and IORGs; (2) responsibilities that may be unique to institutions engaged in human subjects research; and (3) responsibilities that may be fulfilled by either IRBs/IORGs or institutions engaged in human subjects research.
        6a. Are these categories appropriate? If not, what other categories should there be?
        6b. Is there a fourth category of responsibilities that are inherently shared by both the IRB/IORG and the FWA-holding institution? If so, please provide examples of such shared responsibilities.
        6c. Are the regulatory provisions identified under each of the categories appropriate? If not, which regulatory provisions should be re-categorized, removed, or added?
        6d. For institutions that have relied upon joint IRB review arrangements in the past, how have the regulatory requirements been divided or shared by the IRB/IORG and the institution engaged in the human subjects research? We would welcome examples or descriptions of such agreements between IRBs/IORGs and institutions engaged in human subjects research that describe their respective responsibilities.
        7. With regard to the responsibilities that may be fulfilled by either IRBs or institutions, the IRB Authorization Agreement between an external IRB and an FWA-holding institution is often used to clarify which entity will be responsible for carrying out these regulatory requirements.

        7a. If a regulatory change to 45 CFR part 46 is pursued, should OHRP use the IRB Authorization Agreement or other forms of agreement, if they exist (e.g., contract or memorandum of understanding) to inform its compliance oversight evaluations about which entity should be held responsible for fulfilling regulatory requirements that could be met by either an external IRB or the FWA-holding institution?

        7b. If a regulatory change to 45 CFR part 46 is pursued, should there be new provisions that require specific content for IRB Authorization Agreements or for other forms of agreements between external IRBs and FWA-holding institutions? If so, what types of content should be required?
        7c. If a regulatory change to 45 CFR part 46 is pursued, should the regulation describe which regulatory requirements would need to be met by external IRBs and which regulatory requirements would need to be met by institutions engaged in the research?

          Dated: February 27, 2009.
          Jerry Menikoff,
          Director, Office for Human Research Protections.

      [FR Doc. E9-4628 Filed 3-4-09; 8:45 am]
      BILLING CODE 4150-36-P


        FEDERAL COMMUNICATIONS COMMISSION
        47 CFR Part 0
        [WT Docket No. 15-81; FCC 15-40]
        Electronically Stored Application and Licensing Data

          AGENCY:
          Federal Communications Commission.

          ACTION:
          Proposed rule.

          SUMMARY:
          This document proposes to amend the Commission's Rules to specify that historical amateur radio licensee address information will not be routinely available for public inspection.

          DATES:
          Submit comments on or before June 16, 2015 and reply comments are due July 16, 2015.

          ADDRESSES:
          You may submit comments, identified by WT Docket No. 15-81; FCC 15-40, by any of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
          • Federal Communications Commission's Web site: http://www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.
          • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: FCC504@fcc.gov or phone 202-418-0530 or TTY: 202-418-0432.

          For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

          FOR FURTHER INFORMATION CONTACT:
          Scot Stone, at Scot.Stone@fcc.gov, Mobility Division, Wireless Telecommunications Bureau, (202) 418-0638, TTY (202) 418-7233.

        SUPPLEMENTARY INFORMATION:

        This is a summary of the Federal Communications Commission's Notice of Proposed Rulemaking (NPRM), WT Docket No. 15-81; FCC 15-40, adopted March 31, 2015, and released March 31, 2015. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554, or by downloading the text from the Commission's Web site at www.fcc.gov. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to FCC504@fcc.gov or calling the Consumer and Government Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).
        Summary

        1. The Commission initiated this proceeding to amend its rules of organization that apply to amateur radio licensee address information that is routinely available for public inspection. Specifically, the Commission proposes in this NPRM to amend its rules to revise its rules to specify that historical amateur radio licensee address information (that is, address information not associated with a current license or pending application) will not be routinely available for public inspection. The Commission found that amending these rules will enhance amateur radio operators' privacy without undermining the public interest in knowing who is authorized to operate on amateur spectrum. The Commission also seeks comment on whether this approach should be extended to individual licensees in any other Wireless Radio Services, such as the General Mobile Radio Service, commercial radio operator licensees, and individuals who hold ship station and/or aircraft station licenses.
        I. Procedural Matters
        A. Ex Parte Rules—Permit-but-Disclose Proceeding
        2. This is a permit-but-disclose notice and comment rulemaking proceeding. Ex parte presentations are permitted, except during the Sunshine Agenda period, provided they are disclosed as provided in the Commission's rules.
        B. Comment Dates
        3. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, interested parties may file comments on or before June 16, 2015, and reply comments are due July 16, 2015.

        4. Commenters may file comments electronically using the Commission's Electronic Comment Filing System (ECFS), the Federal Government's eRulemaking Portal, or by filing paper copies. Commenters filing through the ECFS can be sent as an electronic file via the Internet to http://www.fcc.gov/e-file/ecfs.html. If multiple docket or rulemaking numbers appear in the caption of this proceeding, filers must transmit one electronic copy for each docket or rulemaking number referenced in the caption. In completing the transmittal screen, commenters should include their full name, U.S. Postal Service mailing address, and the applicable docket or rulemaking number. Commenters may also submit an electronic comment by Internet email. To get filing instructions for email comments, commenters should send an email to ecfs@fcc.gov, and should include the following words in the body of the message, “get form.” Commenters will receive a sample form and directions in reply. Commenters filing through the Federal eRulemaking Portal http://www.regulations.gov, should follow the instructions provided on the Web site for submitting comments.
        5. Commenters who chose to file paper comments must file an original and four copies of each comment. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. All filings must be sent to the Commission's Secretary, Office of the Secretary, Federal Communications Commission, 445 12th Street SW., Room TW-A325, Washington, DC 20554.

        6. Commenters may send filings by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 445 12th Street SW., Washington, DC 20554. Commenters must bind all hand deliveries together with rubber bands or fasteners and must dispose of any envelopes before entering the building. This facility is the only location where the Commission's Secretary will accept hand-delivered or messenger-delivered paper filings. Commenters must send commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) to 9300 East Hampton Drive, Capitol Heights, MD 20743. Commenters should address U.S. Postal Service first-class mail, Express Mail, and Priority Mail to 445 12th Street SW., Washington, DC 20554.
        C. Paperwork Reduction Act

        7. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).
        II. Initial Regulatory Flexibility Analysis
        8. The Regulatory Flexibility Act requires an initial regulatory flexibility analysis to be prepared for notice and comment rulemaking proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).
        9. In the NPRM, we propose to amend the Commission's rules of organization. In this NPRM, we propose to amend the Commission's inspection of records rules to provide that only amateur radio licensee address information connected with current licenses and pending applications is routinely available for public inspection in ULS or in paper files. Because “small entities,” as defined in the RFA, do not include a “person” as the term is used in this proceeding or an individual, the proposed rules do not apply to “small entities.” Rather, they apply exclusively to individuals who are licensees of certain stations or who hold certain Commission authorizations. Therefore, we certify that the proposals in this NPRM, if adopted, will not have a significant economic impact on a substantial number of small entities.
        III. Ordering Clauses
        11. Accordingly, it is ordered, pursuant to sections 4(i), 303(r), and 403 of the Communications Act of 1934, 47 U.S.C. 154(i), 303(r), and 403, that this Notice of Proposed Rulemaking is hereby adopted.

        12. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

          List of Subjects in 47 CFR Part 0
          Organization and functions.

          Federal Communications Commission.
          Marlene H. Dortch,
          Secretary.

        Proposed Rules
        For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 0 as follows:

          PART 0—COMMISSION ORGANIZATION

        1. The authority citation for part 0 continues to read as follows:

          Authority:
          Sec. 5, 48 Stat. 1068, as amended; 47 U.S.C. 155, 225, unless otherwise noted.

        2. Section 0.453 is amended by revising paragraphs (d) introductory text and (d)(4) to read as follows:

          § 0.453
          Public reference rooms.

          (d) Wireless Telecommunications Services and Auction related data as follows, except to the extent they are excluded from routine public inspection under another section of this chapter:

          (4) Electronically stored application and licensing data (including data filed manually and entered into ULS by Commission staff) for commercial radio operators and for all authorizations in the Wireless Radio Services are available for public inspection via the Commission's Web site, http://wireless.fcc.gov/uls. Wireless Radio services include Commercial and Private Mobile Radio, Common Carrier and Private Operational Fixed point-to-point Microwave, Local Television Transmission Service (LTTS), Digital Electronic Message Service (DEMS), Aviation Ground and Marine Coast applications; and

        3. Section 0.457 is amended by revising paragraph (f) to read as follows:

          § 0.457
          Records not routinely available for public inspection.

          (f) Personnel, medical and other files whose disclosure would constitute a clearly unwarranted invasion of personal privacy, 5 U.S.C. 552(b)(6). (1) Under E.O. 10561, the Commission maintains an Official Personnel Folder for each of its employees. Such folders are under the jurisdiction and control, and are a part of the records, of the U.S. Office of Personnel Management. Except as provided in the rules of the Office of Personnel Management (5 CFR 293.311), such folders will not be made available for public inspection by the Commission. In addition, other records of the Commission containing private, personal or financial information concerning particular employees and Commission contractors will be withheld from public inspection.
          (2) With respect to the Amateur Radio Service as that term is defined in § 97.3(a) of this chapter, address information on expired, canceled, or terminated licenses; archived versions of active licenses; and processed applications will not be made available for public inspection by the Commission. For such licensees, disclosure of an individual's historical address information is considered clearly unwarranted invasion of personal privacy.

      [FR Doc. 2015-08810 Filed 4-16-15; 8:45 am]
       BILLING CODE 6712-01-P


        OFFICE OF MANAGEMENT AND BUDGET
        Office of Federal Procurement Policy
        48 CFR Part 9904
        Cost Accounting Standards Board; Allocation of Home Office Expenses to Segments

          AGENCY:
          Cost Accounting Standards Board, Office of Federal Procurement Policy, OMB.

          ACTION:
          Staff Discussion Paper (SDP).

          SUMMARY:
          The Cost Accounting Standards Board (the Board), Office of Federal Procurement Policy, invites public comments on a staff discussion paper (SDP) addressing potential revisions to Cost Accounting Standard (CAS) 403, “Allocation of Home Office Expenses to Segments.” This SDP addresses whether the current thresholds that require use of the three factor formula for allocating residual home office expenses require revision.

          DATES:
          Comments must be in writing and must be received by April 14, 2008.

          ADDRESSES:

          Due to delays in receipt and processing of mail, respondents are strongly encouraged to submit comments electronically to ensure timely receipt. Electronic comments may be submitted to casb2@omb.eop.gov. Please include your name, title, organization, and reference case “CAS-2008-01S.” Comments may also be submitted via facsimile to (202) 395-5105. Comments via regular mail should be addressed to the Office of Federal Procurement Policy, 725 17th Street, NW., Room 9013, Washington, DC 20503, ATTN: Laura Auletta. Please note that any comments received will be posted in their entirety, including any personal and/or business confidential information provided, at http://www.whitehouse.gov/omb/procurement/casb.html after the close of the comment period.

          FOR FURTHER INFORMATION CONTACT:
          Laura Auletta, Manager, Cost Accounting Standards Board, 725 17th Street, NW., Room 9013, Washington, DC 20503 (telephone: 202-395-3256).

        SUPPLEMENTARY INFORMATION:
        A. Regulatory Process
        The Board's rules, regulations and standards are codified at 48 CFR Chapter 99. The Office of Federal Procurement Policy Act, 41 U.S.C. 422(g)(1), requires the Board, prior to the establishment of any new or revised Standard, to complete a prescribed rulemaking process. The process generally consists of the following four steps:
        1. Consult with interested persons concerning the advantages, disadvantages and improvements anticipated in the pricing and administration of government contracts as a result of the adoption of a proposed Standard (i.e., prepare and publish SDP).
        2. Promulgate an Advance Notice of Proposed Rulemaking (ANPRM).
        3. Promulgate a Notice of Proposed Rulemaking (NPRM).
        4. Promulgate a Final Rule.
        The SDP published with this notice is issued by the Board in accordance with the requirements of 41 U.S.C. 422(g)(1)(B), and is the first of the four-step process.
        The Board has received two recommendations to revise the CAS 403 operating revenue thresholds used in determining if a contractor is required to apply the three factor formula to allocate residual home office expenses to segments. The research accomplished to date by the Board staff is the basis for the SDP being released today.
         B. Background
        Over the past few years, the Board has received two proposals to revise the CAS operating revenue thresholds for determining if a contractor is required to use the three factor formula to allocate residual home office expenses to segments.

          1. Consumer Price Index: A proposal from the Aerospace Industries Association (AIA) recommends that the operating revenue thresholds be raised by 400 percent to reflect the changes in the consumer price index (CPI) from 1973 to 2003.

          2. Conduct Staff Study: A proposal from the Department of Defense (DoD) recommends that the Board obtain actual statistics of various companies and conduct a staff study similar to that performed by the original Board. This proposal recommends that the study update the thresholds to reflect the impact that economic changes, industry changes, and the advent of acquisition reform have had in the years since the thresholds were established.
        C. Staff Discussion Paper
        I. Background
        • 48 CFR 9904.403-40(c)(2) requires that home office residual expenses be allocated to segments using the three factor formula if the residual expenses exceed:
        ○ 3.35 percent of the first $100 million of operating revenue;
        ○ .95 percent of the next $200 million of operating revenue;
        ○ .30 percent of the next $2.7 billion of operating revenue; and
        ○ .20 percent of all amounts over $3 billion of operating revenue.
        • The operating revenue thresholds at 48 C.F.R 9904.403-40(c)(2) were promulgated in December 1972 and have not been revised in the 35 years since.
        • The Board has decided to initiate a case to determine if the current thresholds require revision. This case will analyze all aspects of this issue. For example, in addition to the inflation of the dollar, the last 35 years have also seen a change in the nature of home offices. In particular, the number of home offices have significantly increased due to the proliferation of intermediate home offices. In determining whether to revise the current thresholds, the Board will need to analyze if and to what extent such a proliferation impacts the thresholds. In addition, the Board will need to determine if and to what extent a data call is needed to obtain information necessary to reach an informed decision on this issue.
        II. Staff Research
        Comments on Alternatives

          1. Use Consumer Price Index (CPI): On August 26, 2003, AIA sent a letter to the Board recommending that the operating revenue thresholds be raised by 400 percent to reflect the changes in the CPI from 1973 to 2003. The staff believes the AIA recommendation offers the advantage of a simple and quick revision to the out-of-date thresholds. It is also an objective measure of the economic escalation that has occurred since the thresholds were initially promulgated. A significant disadvantage is that the increase in the CPI may not be a good measure of increases necessary to the three factor formula. For example, the number of home offices have significantly increased due to the proliferation of intermediate home offices. The increase in home offices may warrant a smaller increase in the three factor formula than the CPI would provide. A second disadvantage is that the Board will not be aware of the exact impact the revision will have on the number of companies covered by the three factor formula.
        The CPI represents changes in prices of all goods and services purchased for consumption by urban households. User fees (such as water and sewer service) and sales and excise taxes paid by the consumer are also included. Income taxes and investment items (like stocks, bonds, and life insurance) are not included. It is an objective measure of the economic escalation that has occurred since the thresholds were initially promulgated.
        A potential problem concerning the use of the CPI is that historical values are not revised when there are improvements in the index. Consequently, past errors in methodology are only corrected prospectively (i.e., the historical data is not corrected). Most of the major improvements in the CPI have tended to reduce measured inflation. As a result, the increase in the CPI since 1972 overstates inflation.
        The overstatement in the CPI can be mitigated by using alternative versions that incorporate current methodology in measuring past price movements. From 1972 to 1978, the best alternative version is the CPI-U-X1, which provides an adjustment to the CPI that computes housing costs using rental equivalents (this method was adopted for the official CPI in the early 1980s). However, the CPI-U-X1 does not include other improvements to the CPI that were adopted in the early 1980s.
        The CPI-U-RS, which was developed in the late 1990s, incorporates changes in methodology implemented since 1978. Thus, it can be used to analyze inflationary trends in the CPI without interference from changes in methodology. New values based on current methods are released each April.

        From December 1972 through December 1977, the CPI-U-X1 increased by a factor of 1.43. From January 1978 through February 2007, the CPI-U-RS increased by a factor of 3.26. To compute the increase for the period December 1972 through February 2007, the factor for the CPI-U-X1 is multiplied by the factor for the CPI-U-RS (1.43 x 3.26) to obtain an inflation factor of 4.66.
        Applying this factor to the current thresholds at 48 C.F.R 9904.403-50 yields the following revised thresholds for application of the three factor formula:
        ○ 3.35 percent of the first $470 million of operating revenue;
        ○ .95 percent of the next $930 million of operating revenue;
        ○ .30 percent of the next $12.6 billion of operating revenue; and
        ○ .20 percent of all amounts over $14.0 billion of operating revenue.

          2. Conduct Staff Study: On September 26, 2002, DoD sent a letter to the Board recommending that, as part of the comprehensive review, the Board obtain actual statistics of various companies and conduct a staff study similar to that performed by the original Board. DoD recommended that the study update the thresholds to reflect the impact that economic changes, industry changes, and the advent of acquisition reform have had in the years since the thresholds were established. The staff believes that the DoD recommendation offers the Board an opportunity to understand the impact that various revisions would have on the number of companies subject to the three factor formula before drafting an ANPRM. The disadvantage is that the analysis will require significant time and effort to accomplish, and it is possible that such an analysis would not yield useful data for determining the appropriate thresholds.
        III. Public Input
        The Board is requesting public input on whether the thresholds should be raised, the potential advantages and disadvantages of the two alternatives described above, and any additional recommended alternatives the commenters may have. Key questions for consideration include, but are not limited to, the following:
        1. Should the operating revenue thresholds be revised? Why or why not?
        2. If the threshold should be revised, what should be the basis of that revision (e.g., CPI, staff study, other)?
        3. What are the advantages and disadvantages of the two alternatives described above?
        4. What type of data is currently available for performance of the staff study?
        5. Is the administrative burden of collecting the data associated with the staff study commensurate with risk?
        6. To what extent does the proliferation of intermediate home offices impact any potential revision of the operating revenue thresholds?

          Paul A. Denett,
          Administrator, Office of Federal Procurement Policy.

       [FR Doc. E8-2666 Filed 2-12-08; 8:45 am]
      BILLING CODE 3110-01-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 622
        [Docket No. 130403322-4180-01]
        RIN 0648-BD08
        Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Dolphin and Wahoo Fishery Off the Atlantic States; Amendment 5

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments.

          SUMMARY:
          NMFS proposes regulations to implement Amendment 5 (Amendment 5) to Fishery Management Plan for the Dolphin and Wahoo Fishery off the Atlantic States (FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council). If implemented, this rule would revise the annual catch limits (ACLS) and accountability measures (AMs) for the commercial and recreational sectors for dolphin and wahoo, and update the framework procedures for the FMP. The purpose of this rule is to help achieve optimum yield (OY) within the dolphin and wahoo fishery and to minimize socio-economic impacts, to the extent practicable, in accordance with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

          DATES:
          Written comments must be received on or before April 14, 2014.

          ADDRESSES:
          You may submit comments on the proposed rule, identified by “NOAA-NMFS-2013-0170” by any of the following methods:
          • Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2013-0170, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.
          • Mail: Submit written comments to Nikhil Mehta, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701.

            Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.

          Electronic copies of the amendment, which includes an environmental assessment, regulatory impact review, and Regulatory Flexibility Act analysis, may be obtained from the Southeast Regional Office Web site at http://sero.nmfs.noaa.gov/sustainable_fisheries/s_atl/dw/2013/am5/index.html.

          FOR FURTHER INFORMATION CONTACT:
          Nikhil Mehta, telephone: 727-824-5305, or email: nikhil.mehta@noaa.gov.

        SUPPLEMENTARY INFORMATION:
        The dolphin and wahoo fishery off the Atlantic states is managed under the FMP. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act.
        Background
        The final rule for the Comprehensive ACL Amendment included Amendment 3 to the FMP, which established ACLs (including ACL allocations to both the recreational and commercial sectors), acceptable biological catches (ABCs), recreational annual catch targets (ACTs), and accountability measures (AMs) for dolphin and wahoo (77 FR 15916, March 16, 2012). Recreational catch estimates used in the Comprehensive ACL Amendment were determined with data collected by the Marine Recreational Fisheries Statistics Survey (MRFSS), which was the best scientific information available at that time. NMFS has made significant improvements in the data collection and catch estimation methodologies that are used to collect and analyze the recreational data for the computation of ABCs, as well as ACLs and ACTs. NMFS now estimates recreational landings using the Marine Recreational Information Program (MRIP).
        The MRIP collects recreational data on a more frequent basis and provides more accurate recreational catch estimates by accounting for potential biases such as possible differences in catch rates at high-activity and low-activity fishing sites, as well as variation in fishing effort throughout the day. As described in Amendment 5, the MRIP values used to estimate recreational landings, along with updates to headboat and commercial landings, are the best scientific information available to revise the ABC catch estimates, ACLs, recreational ACTs, and AMs for dolphin and wahoo. Updates to the commercial and headboat landings were included in the revisions to the ACLs and ACTs, because the ABC control rule and subsequent ABCs and ACLs established in the Comprehensive ACL Amendment used data from both the recreational and commercial sectors (77 FR 15916, March 16, 2012). The headboat and commercial data updates reflect NMFS's ongoing data quality assurance and quality control protocols and reflect the best available scientific information.
        These revisions are necessary because if the ABC, ACL, and ACT values are not updated using the new MRIP estimates, the recreational ACLs would be based on MRFSS data, while the landings being used to track the recreational ACLs would be estimated using MRIP data. If this change is not made, it would result in inconsistencies in how the ACLs are calculated versus how the ACLs are monitored.
        Management Measures Contained in This Proposed Rule
        This proposed rule would revise the ACLs and AMs for dolphin and wahoo, and revise the framework procedures for the FMP.
        Dolphin Commercial and Recreational ACLs
        This proposed rule would revise the dolphin commercial and recreational ACLs. The dolphin commercial ACL would be increased from 1,065,524 lb (483,314 kg) to 1,157,001 lb (524,807 kg). The dolphin recreational ACL would be increased from 13,530,692 lb (6,137,419 kg) to 14,187,845 lb (6,435,498 kg). The effects of the increases in the ACLs for dolphin are expected to be negligible to the stock and the human environment.
        Wahoo Commercial and Recreational ACLs
        This proposed rule would revise the wahoo commercial and recreational ACLs. The wahoo commercial ACL would be increased from 64,147 lb (29,097 kg) to 70,542 lb (31,997 kg). The wahoo recreational ACL would be increased from 1,427,638 lb (647,566 kg) to 1,724,418 lb (782,183 kg). The effects of the increases in ACLs for wahoo are expected to be negligible to the stock and the human environment.
        Dolphin and Wahoo Commercial AMs
        The current commercial AMs for dolphin and wahoo close the commercial sector for the respective species for the remainder of the fishing year, if commercial landings as estimated by the Science and Research Director (SRD) reach, or are projected to reach, the commercial ACL (in-season closure).

        This proposed rule would also provide that if the commercial ACL is met or projected to be met, then the commercial ACL for the respective species in the following fishing year would be reduced by the amount of the commercial ACL overage. However, the commercial ACL overage adjustment would only be applied if the species is overfished and the total ACL (combined commercial and recreational ACLs) is exceeded. The Council determined the commercial ACL overage adjustment (payback), combined with the in-season AM closure would offer greater protection to the stocks and provided the best management strategy for the commercial sector based on the biology and recent catch levels of dolphin and wahoo.
        Dolphin and Wahoo Recreational AMs
        The current recreational AMs for dolphin and wahoo provide that if recreational landings, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year, recreational landings will be monitored for a persistence in increased landings and, if necessary, the NMFS Southeast Regional Administrator (RA) shall publish a notice to reduce the length of the following recreational fishing season by the amount necessary to ensure recreational landings do not exceed the recreational ACL in the following fishing year. However, the length of the recreational season will also not be reduced during the following fishing year if the RA determines, using the best scientific information available, that a reduction in the length of the following fishing season is unnecessary.
        This proposed rule would modify the recreational AM to reduce the length of the fishing season and the recreational ACL in the fishing year following any recreational sector ACL overage, if the stock is overfished and the total ACL (commercial and recreational ACLs combined) is exceeded. However, the recreational ACL overage adjustment and fishing season reduction would not be applied if the RA determines, using the best scientific information available, that such a reduction is unnecessary. The ability to reduce the recreational ACL when an overage of the respective ACL occurs would provide additional protection to the dolphin and wahoo stocks. The Council determined that this set of AMs best meets the objectives of the FMP, while complying with the requirements of the Magnuson-Stevens Act.
        Dolphin and Wahoo FMP Framework Procedures
        The current framework procedure for dolphin and wahoo was implemented in 2004 through the FMP (69 FR 30235, May 27, 2004). While comprehensive, the framework does not incorporate recent developments such as ACLs, ABC control rule, AMs, and the roles of the Council's Southeast Data, Assessment, and Review (SEDAR) process for stock assessments, and Scientific and Statistical Committee's (SSC) role in reviewing SEDAR data for the Council.
        This proposed rule would revise the framework procedures for the FMP to add an ABC control rule, ACLs, ACTs, and AMs to the measures that could be revised via the regulatory amendment process. Additionally, this proposed rule would allow an ABC, ACL, and ACT to be modified using an abbreviated framework procedure, whereby after the Council has taken final action to change an ABC, ACL, and/or ACT, the Council would submit a letter to the RA containing an analysis of the relevant biological, economic, social, and administrative information necessary to support the action. Based on the information provided by the Council, the RA would determine whether or not the requested modifications are warranted. If the requested modifications may be warranted, NMFS would develop the appropriate documentation to comply with the National Environmental Policy Act and other applicable law, and propose the action through rulemaking. NMFS anticipates this expedited process will shorten the time it would take to make routine changes to harvest limits in response to new scientific information, while allowing the public adequate time to comment on any change.
        Additional Measures in Amendment 5 That Are Not Contained in This Proposed Rule
        In addition to the measures in this proposed rule, this rule publishes for the public's convenience, certain measures contained in Amendment 5. Amendment 5 would revise the ABCs and recreational ACTs for dolphin and wahoo. Amendment 5 would increase the ABC for dolphin from 14,596,216 lb (6,620,732 kg) to 15,344,846 lb (6,960,305 kg). The ABC for wahoo would increase from 1,491,785 lb (676,662 kg) to 1,794,960 lb (814,180 kg). The revised ABCs would be established using MRIP data as opposed to using MRFSS data, as was used to establish the current ABCs.
        Amendment 5 would also increase the current dolphin recreational ACT of 11,595,803 lb (5,259,768 kg) to 12,769,061 (5,791,949 kg) and the current wahoo recreational ACT of 1,164,953 lb (528,414 kg) to 1,258,825 lb (570,993 kg). The current recreational ACTs for dolphin and wahoo, implemented in the Comprehensive ACL Amendment, function as performance standards, and do not have management measures associated with them, such as triggering AMs (77 FR 15916, March 16, 2012).
        Classification
        Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Assistant Administrator has determined that this proposed rule is consistent with Amendment 5, the FMP, Magnuson-Stevens Act and other applicable law, subject to further consideration after public comment.
        This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
        The Magnuson-Stevens Act provides the statutory basis for this rule.
        The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:
        This proposed rule is expected to directly affect commercial fishermen and for-hire operators in the Atlantic. The SBA established size criteria for all major industry sectors in the U.S. including fish harvesters and for-hire operations. A business involved in fish harvesting is classified as a small business if independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $19.0 million (NAICS code 114111, finfish fishing) for all of its affiliated operations worldwide. For for-hire vessels, other qualifiers apply and the annual receipts threshold is $7.0 million (NAICS code 487210, fishing boat charter operation). The SBA periodically reviews and changes, as appropriate, these size criteria. On June 20, 2013, the SBA issued a final rule revising the small business size standards for several industries effective July 22, 2013 (78 FR 37398). That rule increased the size standard for commercial finfish harvesters from $4.0 million to $19.0 million. Neither that rule, nor other recent SBA rules, changed the size standard for for-hire vessels.

        From 2008-2012, an annual average of 554 vessels with valid Federal permits to operate in the commercial sector of the Atlantic dolphin-wahoo fishery landed at least 1 lb (0.6 kg) of dolphin. These vessels generated average annual dockside revenues of approximately $4.4 million (2011) from all species caught in the same trips as dolphin, of which $591,000 (2011 dollars) were from dolphin. Each commercial vessel, therefore, generated an annual average of approximately $8,000 in gross revenues, of which $1,000 were from dolphin. For the same period, an annual average of 211 vessels with valid Federal permits to operate in the commercial sector of the dolphin-wahoo fishery landed at least 1 lb (0.6 kg) of wahoo. These vessels generated annual dockside revenues of approximately $673,000 (2011) from all species caught in the same trips as wahoo, of which $71,000 (2011 dollars) were from wahoo. Each vessel, therefore, generated an annual average of approximately $3,183 in gross revenues, of which $335 were from wahoo. Vessels that caught and landed dolphin or wahoo may also operate in other fisheries, the revenues of which are not reflected in these totals. Based on revenue information, all commercial vessels affected by the rule can be considered small entities.
        From 2008-2012, an annual average of 2,005 vessels had valid or renewable Federal permits to operate in the for-hire component of the recreational sector of the Atlantic dolphin-wahoo fishery. As of April 23, 2013, 1,623 vessels held a Federal charter/headboat permit for Atlantic dolphin/wahoo, and about 75 of those vessels are estimated to have operated as headboats in 2013. The for-hire fleet consists of charter boats, which charge a fee on a vessel basis, and headboats, which charge a fee on an individual angler (head) basis. Average annual revenues (2011 dollars) for charter boats are estimated to be $126,032 for Florida vessels, $53,443 for Georgia vessels, $100,823 for South Carolina vessels, and $101,959 for North Carolina vessels. For headboats, the corresponding estimates are $209,507 for Florida vessels and $153,848 for vessels in the other states. Headboat revenues for states other than Florida are aggregated to prevent disclosure of otherwise confidential information. For the Northeast (states north of North Carolina), in 2010, the average gross revenue for headboats was approximately $214,000 and $28,000 for charter vessels. The Northeast information is not currently available on a state by state basis. Based on these average revenue figures, all for-hire operations that would be affected by the rule can be considered small entities.
        This proposed rule would revise the ABCs, ACLs, and ACTs for dolphin and wahoo to reflect data from MRIP and other data updates. The resulting revisions would slightly increase the values for these parameters, thus resulting in slight economic benefits for the dolphin and wahoo commercial and recreational sectors.
        This proposed rule would revise the commercial and recreational AMs for dolphin and wahoo by introducing ACL overage adjustment (payback) provisions, but only if the stocks are overfished and the aggregate commercial and recreational ACLs are exceeded. Since dolphin is currently neither overfished nor undergoing overfishing, introduction of a payback provision has no short-term economic effects on the commercial and recreational sectors. Although a stock assessment for wahoo will be done in 2015, there are indications that the stock is healthy because of its life history. In addition, and based on the last 5 years of landings, both the commercial and recreational sector ACLs for wahoo are unlikely to be exceeded during a fishing year in the near future. These revisions to the AMs for dolphin and wahoo are therefore expected to have no short-term economic effects on small entities.
        NMFS considered one alternative, the “no action” alternative, to the commercial and recreational AMs for dolphin and wahoo. The no action alternative does not have payback provisions; however, AMs would apply regardless of stock status. In addition, the application of sector-specific AMs is dependent only on a sector's ACL being exceeded or expected to be exceeded and not on the aggregate commercial and recreational ACLs.
        This proposed rule would also modify the framework procedures for the FMP. The proposed revisions are administrative in nature and therefore have no direct economic effects on small entities.
        No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. Accordingly, this rule does not implicate the Paperwork Reduction Act.
        The information provided above supports a determination that this rule would not have a significant economic impact on a substantial number of small entities. Because this rule, if implemented, is not expected to have significant economic impact on any small entities, an initial regulatory flexibility analysis is not required and none has been prepared.

          List of Subjects in 50 CFR Part 622
          Atlantic, Dolphin, Fisheries, Fishing, Wahoo.

          Dated: March 7, 2014.
          Samuel D. Rauch III,
          Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

        For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

          PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC

        1. The authority citation for part 622 continues to read as follows:

          Authority:
           16 U.S.C. 1801 et seq.

        2. In § 622.280, paragraphs (a) and (b) are revised to read as follows:

          § 622.280
          Annual catch limits (ACLs) and accountability measures (AMs).
          (a) Atlantic dolphin—(1) Commercial sector. (i) If commercial landings for Atlantic dolphin, as estimated by the SRD, reach or are projected to reach the commercial ACL of 1,157,001 lb (524,807 kg), round weight, the AA will file a notification with the Office of the Federal Register to close the commercial sector for the remainder of the fishing year. On and after the effective date of such a notification, all sale or purchase of Atlantic dolphin is prohibited and harvest or possession of this species in or from the South Atlantic EEZ is limited to the bag and possession limit. This bag and possession limit applies in the South Atlantic on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for Atlantic dolphin and wahoo has been issued, without regard to where such species were harvested, i.e., in state or Federal waters.
          (ii) In addition to the measures specified in paragraph (a)(1)(i) of this section, if the combined Atlantic dolphin commercial and recreational landings exceed the combined commercial and recreational ACLs specified in paragraphs (a)(1)(i) and (a)(2)(i) of this section, and Atlantic dolphin are overfished, based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register, at or near the beginning of the following fishing year, to reduce the commercial ACL for that following year by the amount of the commercial overage in the prior fishing year.
          (2) Recreational sector. (i) If recreational landings for Atlantic dolphin, as estimated by the SRD, exceed the recreational ACL of 14,187,845 lb (6,435,498 kg), round weight, then during the following fishing year, recreational landings will be monitored for a persistence in increased landings.

          (ii) If the combined Atlantic dolphin commercial and recreational landings exceed the combined commercial and recreational ACLs specified in paragraphs (a)(1)(i) and (a)(2)(i) of this section, and Atlantic dolphin are overfished, based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register, at or near the beginning of the following fishing year, to reduce the recreational ACL for that following year by the amount of the recreational overage in the prior fishing year, and reduce the recreational fishing season by the amount necessary to ensure recreational landings do not exceed the reduced ACL. However, the recreational ACL and the length of the recreational fishing season will not be reduced during the following fishing year if the RA determines, using the best scientific information available, that a reduced recreational ACL and a reduction in the length of the following fishing season is unnecessary.
          (b) Atlantic wahoo—(1) Commercial sector. (i) If commercial landings for Atlantic wahoo, as estimated by the SRD, reach or are projected to reach the commercial ACL of 70,542 lb (31,997 kg), round weight, the AA will file a notification with the Office of the Federal Register to close the commercial sector for the remainder of the fishing year. On and after the effective date of such a notification, all sale or purchase of Atlantic wahoo is prohibited and harvest or possession of this species in or from the South Atlantic EEZ is limited to the bag and possession limit. This bag and possession limit applies in the South Atlantic on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for Atlantic dolphin and wahoo has been issued, without regard to where such species were harvested, i.e., in state or Federal waters.
          (ii) In addition to the measures specified in paragraph (b)(1)(i) of this section, if the combined Atlantic wahoo commercial and recreational landings exceed the combined commercial and recreational ACLs specified in paragraphs (b)(1)(i) and (b)(2)(i) of this section, and Atlantic wahoo are overfished, based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register, at or near the beginning of the following fishing year, to reduce the commercial ACL for that following year by the amount of the commercial overage in the prior fishing year.
          (2) Recreational sector. (i) If recreational landings for Atlantic wahoo, as estimated by the SRD, exceed the recreational ACL of 1,724,418 lb (782,183 kg), round weight, then during the following fishing year, recreational landings will be monitored for a persistence in increased landings.
          (ii) If the combined Atlantic wahoo commercial and recreational landings exceed the combined commercial and recreational ACLs specified in paragraphs (b)(1)(i) and (b)(2)(i) of this section, and Atlantic wahoo are overfished, based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register, at or near the beginning of the following fishing year, to reduce the recreational ACL for that following year by the amount necessary to ensure recreational landings do not exceed the reduced ACL. However, the recreational ACL and the length of the recreational fishing season will not be reduced during the following year if the RA determines, using the best scientific information available, that a reduced recreational ACL and a reduction in the length of the following fishing season is unnecessary.

        3. In § 622.281, paragraph (a) is revised to read as follows:

          § 622.281
          Adjustment of management measures.

          (a) Atlantic dolphin and wahoo. Biomass levels, age-structured analyses, MSY, OY, OFL, TAC, ABC, ABC Control Rule, ACLs, ACTs, AMs, trip limits, minimum sizes, gear regulations and restrictions, permit requirements, seasonal or area closures, sub-zones and their management measures, overfishing definitions and other status determination criteria, time frame for recovery of Atlantic dolphin or wahoo if overfished, fishing year (adjustment not to exceed 2 months), authority for the RA to close a fishery when a quota is reached or is projected to be reached or reopen a fishery when additional quota becomes available, definitions of essential fish habitat, and essential fish habitat HAPCs or Coral HAPCs.

      [FR Doc. 2014-05581 Filed 3-13-14; 8:45 am]
      BILLING CODE 3510-22-P