        DEPARTMENT OF TRANSPORTATION
        Federal Motor Carrier Safety Administration
        49 CFR Part 395
        [Docket No. FMCSA-2018-0248]
        RIN 2126-AC19
        Hours of Service of Drivers

          AGENCY:
          Federal Motor Carrier Safety Administration (FMCSA), DOT.

          ACTION:
          Advance notice of proposed rulemaking (ANPRM).

          SUMMARY:

          The introduction of electronic logging devices and their ability to accurately record compliance with hours-of-service (HOS) regulations for drivers of commercial motor vehicles (CMVs) have prompted numerous requests from Congress and the public for FMCSA to consider revising certain HOS provisions. To address these requests, FMCSA seeks public input in four specific areas in which the Agency is considering changes: The short-haul HOS limit; the HOS exception for adverse driving conditions; the 30-minute rest break provision; and the sleeper berth rule to allow drivers to split their required time in the sleeper berth. In addition, the Agency seeks public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). OOIDA petitioned the Agency to amend the HOS rules to allow drivers to take a rest break once per 14-hour duty period for up to three consecutive hours if the driver is off-duty. OOIDA's petition also requests that the Agency eliminate the 30-minute rest break requirement which the Agency had identified as an area of consideration for rulemaking. TruckerNation petitioned the Agency to revise the prohibition against driving after the 14th hour of the beginning of the work shift, allow drivers to use multiple off-duty periods of three hours or longer in lieu of having 10 consecutive hours off-duty, and eliminate the 30-minute rest break requirement.

          DATES:
          Comments on this ANPRM must be received on or before September 24, 2018.

          ADDRESSES:
          You may submit comments identified by Docket Number FMCSA-2018-0248 using any of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
          • Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001.
          • Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
          • Fax: 202-493-2251.
          • Submissions Containing Confidential Business Information (CBI): Mr. Brian Dahlin, Chief, Regulatory Evaluation Division, 1200 New Jersey Avenue SE, Washington, DC 20590.

          To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for instructions on submitting comments, including collection of information comments for the Office of Information and Regulatory Affairs, OMB.

          FOR FURTHER INFORMATION CONTACT:
          Mr. Thomas Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, (202) 366-4325.
          If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

        SUPPLEMENTARY INFORMATION:
        This ANPRM is organized as follows:

          I. Public Participation and Request for Comments
          A. Submitting Comments
          B. Viewing Comments and Documents
          C. Privacy Act
          D. Public Meeting
          II. Abbreviations and Acronyms
          III. Legal Basis for the Rulemaking
          IV. Background
          A. Short-Haul Operations
          B. Adverse Driving Conditions
          C. 30-Minute Break
          D. Split-Sleeper Berth
          V. Comments Sought

        I. Public Participation and Request for Comments
        A. Submitting Comments
        If you submit a comment, please include the docket number for this ANPRM (Docket No. FMCSA-2018-0248), indicate the specific section of this document to which each section applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
        To submit your comment online, go to http://www.regulations.gov, put the docket number, FMCSA-2018-0248, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.
        If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.
        FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments. Late comments will be considered to the extent practicable. FMCSA may issue a proposed rule at any time after the close of the comment period.
        Confidential Business Information
        Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the general public by the submitter. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CBI that is relevant or responsive to this ANPRM, it is important that you clearly designate the submitted comments as CBI. Accordingly, please mark each page of your submission as “confidential” or “CBI.” Submissions designated as CBI and meeting the definition noted above will not be placed in the public docket of this ANPRM. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, 1200 New Jersey Avenue SE, Washington, DC 20590. Any commentary that FMCSA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
        FMCSA will consider all comments and material received during the comment period.
        B. Viewing Comments and Documents

        To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2018-0248, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.
        C. Privacy Act

        In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

        II. Abbreviations and Acronyms

          CMV Commercial motor vehicle
          DOT Department of Transportation
          ELD Electronic logging device
          FR Federal Register
          HOS Hours of service
          U.S.C. United States Code

        III. Legal Basis for the Rulemaking
        This ANPRM is based on the authority of the Motor Carrier Act of 1935 and the Motor Carrier Safety Act of 1984 (1984 Act). The Motor Carrier Act of 1935 provides that “The Secretary of Transportation may prescribe requirements for (1) qualifications and maximum hours of service of employees of, and safety of operation and equipment of, a motor carrier; and, (2) qualifications and maximum hours of service of employees of, and standards of equipment of, a motor private carrier, when needed to promote safety of operation.” (49 U.S.C. 31502(b)).
        The HOS regulations discussed below concern the “maximum hours of service of employees of . . . a motor carrier” (49 U.S.C. 31502(b)(1)) and the “maximum hours of service of employees of . . . a motor private carrier[.]” (49 U.S.C. 31502(b)(2)). The adoption and enforcement of such rules were specifically authorized by the Motor Carrier Act of 1935. This ANPRM rests in part on that authority.
        The 1984 Act provides concurrent authority to regulate drivers, motor carriers, and vehicle equipment. It requires the Secretary of Transportation to “prescribe regulations on commercial motor vehicle safety. The regulations shall prescribe minimum safety standards for commercial motor vehicles.” Although this authority is very broad, the 1984 Act also includes specific requirements: “At a minimum, the regulations shall ensure that (1) commercial motor vehicles are maintained, equipped, loaded, and operated safely; (2) the responsibilities imposed on operators of commercial motor vehicles do not impair their ability to operate the vehicles safely; (3) the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely . . .; and (4) the operation of commercial motor vehicles does not have a deleterious effect on the physical condition of the operators[.]” (49 U.S.C. 31136(a)).
        This ANPRM is also based on the authority of the 1984 Act, specifically section 31136(a)(2) and, less directly, sections 31136(a)(3) and (4). To the extent section 31136(a)(1) focuses on the mechanical condition of CMVs, that subject is not included in this rulemaking. However, as the phrase “operated safely” in paragraph (a)(1) also addresses safe driving practices, this proposed rule also addresses that mandate.
        Before prescribing any regulations, FMCSA must also consider their “costs and benefits” (49 U.S.C. 31136(c)(2)(A) and 31502(d)). The Agency seeks information on those factors in this ANPRM.
        IV. Background
        Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, issued on January 30, 2017, directs executive agencies of the Federal government to “manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations.” (82 FR 9339). E.O. 13777, Enforcing the Regulatory Reform Agenda, issued on February 24, 2017, sets forth regulatory reform initiatives and policies to “alleviate unnecessary regulatory burdens placed on the American people.” [82 FR 12285]. In accordance with those Presidential directives and based upon its experience and expertise, FMCSA reviewed the driver HOS regulations and, as explained below, seeks information in the following four areas to determine if revisions may alleviate unnecessary regulatory burdens while maintaining CMV driver and motor carrier safety, as well as the safety of the public. On May 17, 2018 Administrator Martinez received a letter signed by 30 Senators expressing support for greater flexibility within hours of service regulations. In addition, numerous pieces of legislation were proposed or introduced in both chambers of Congress to address reforming current regulations.
        Briefly, the HOS rules limit CMV drivers to 11 hours of driving time within a 14-hour window after coming on duty following 10 consecutive hours off duty (except that drivers who use sleeper berths may combine 2 hours of off-duty time with 8 consecutive hours in the sleeper berth). Drivers must take at least 30 minutes off duty no later than 8 hours after coming on duty if they wish to continue driving after the 8th hour. Drivers must record their on- and off-duty time in records of duty status (RODS)—previously captured in paper “logs” but today (with some exceptions) through electronic logging devices (ELDs). Drivers may not drive after having accumulated 60 hours of on-duty time in 7 consecutive days, or 70 hours in 8 days, but they may restart the 60/70-hour “clock” by taking 34 consecutive hours off duty.
        A. Short-Haul Operations
        Under 49 CFR 395.1(e)(1)(ii)(A), drivers do not have to prepare RODS or use an ELD if they meet certain conditions, including a return to their work reporting location and release from work within 12 consecutive hours. Drivers operating under this provision therefore have a 12-hour window in which to drive up to 11 total hours. Other truck (though not bus) drivers have a 14-hour window in which to drive up to 11 total hours. [49 CFR 395.3(a)(2)-(3)].
        B. Adverse Driving Conditions
        The current rule in § 395.1(b)(1) allows 2 additional hours of driving time under adverse conditions, which are defined in § 395.2 as “snow, sleet, fog, other adverse weather conditions, a highway covered with snow or ice, or unusual road and traffic conditions, none of which were apparent on the basis of information known to the person dispatching the run at the time it was begun.” Although the rule allows up to 13 hours of driving time under adverse conditions, instead of the normal 11 hours, it does not provide a corresponding extension of the 14-hour driving window to 16 hours.
        C. 30-Minute Break
        Under 49 CFR 395.3(a)(3)(ii), except for drivers who qualify for either of the short-haul exceptions in § 395.1(e)(1) or (2), driving is not permitted if more than 8 hours have passed since the end of the driver's last off-duty or sleeper-berth period of at least 30 minutes. (The 30-minute break rule does not apply to drivers who operate CMVs within a 100 air-mile radius of their normal work-reporting location and return to that location within 12 hours, as authorized by § 395.1(e)(1), or to drivers who do not need a Commercial Driver's License (CDL), operate within a 150 air-mile radius of their work reporting location, and meet certain other requirements, as authorized by § 395.1(e)(2)).
        D. Split Sleeper Berth Time

        There are special HOS rules for CMV drivers who operate vehicles equipped with a sleeper-berth. In essence, these rules allow a sleeper-berth user to divide the minimum 10 hours off-duty into an equivalent two separate periods. Drivers who use sleeper berths, as defined in § 393.76, must take at least 8 consecutive hours of the 10-hour off-duty period in the sleeper berth as required by § 395.1(g)(1)(ii)(A)(1). In addition to the 8- through 10-hour sleeper-berth period, in order to acquire additional driving time the driver using the sleeper berth exception must, either earlier or later in the duty period, have a separate period of at least 2 hours off-duty, which may be in the sleeper berth if desired. It does not matter which rest period is taken first. After the second required rest period is completed, the driver will have a new point on the clock from which to calculate hours available.

        The Agency also announced a proposal on “Pilot Program To Allow Commercial Drivers To Split Sleeper Berth Time” on June 6, 2017 (82 FR 26232). This program, planned for Fall 2018, would monitor a limited number of commercial drivers with CDLs and who regularly use a sleeper berth to accumulate their required 10 hours of non-duty work status. During the pilot program, participating drivers would have the option to split their sleeper berth time into two periods, each of which must be at least 2 hours long. Driver metrics would be collected for the duration of the study, and participants' safety performance and fatigue levels will be analyzed. Additional information on the pilot program, including the timeline, can be found at: https://www.fmcsa.dot.gov/research-and-analysis/research/flexible-sleeper-berth-pilot-program.

        E. OOIDA Petition for Rulemaking
        On February 13, 2018, OOIDA petitioned FMCSA to amend the HOS rules to allow drivers to take a rest break once per 14-hour duty period for up to 3 consecutive hours if the driver is off-duty. OOIDA explained that the rest break would effectively stop the 14-hour clock. It would also extend to the 17th hour after coming on duty (instead of the current 14th hour) the latest time a driver could drive after coming on duty. However, drivers would still be limited to 11 hours of driving time and required to have at least 10 consecutive hours off duty before the start of the next work shift.
        OOIDA's petition also included a request that the Agency eliminate the 30-minute rest break requirement. The organization explained that there are many operational situations where the 30-minute rest break requires drivers to stop when they do not feel tired.
        A copy of OOIDA's petition is included in the docket referenced at the beginning of this ANPRM.
        F. TruckerNation.org (TruckerNation) Petition for Rulemaking
        On May 10, 2018, TruckerNation petitioned the Agency to revise the prohibition against driving after the 14th hour after the beginning of the work shift. As an alternative, the organization requested that the Agency prohibit driving after the driver has accumulated 14-hours of on-duty time.
        In addition, TruckerNation requested that FMCSA allow drivers to use multiple off-duty periods of three hours or longer in lieu of having 10 consecutive hours off-duty, and eliminate the 30-minute rest break requirement.
        TruckerNation believes the requested changes to the HOS requirements would achieve a level of safety that is equivalent to, or greater than, the level of safety that is provided by the current regulations.
        A copy of TruckerNation's petition is included in the docket referenced at the beginning of this ANPRM.
        V. Comments Sought

        The Agency specifically seeks comments and data from the public in response to this ANPRM. We request that commenters address their comments specifically to the enumerated list of issues below, and number their comments to correspond to each issue. FMCSA anticipates that some of the information and data sought may include confidential business information. These comments should be filed in accordance with the requirements of 49 CFR 389.9 Treatment of confidential business information and the instructions under the subheading Confidential Business Information, under the headings ADDRESSES and Public Participation and Request for Comments.
        1. Short-haul operations.
        a. Do you have any data to show that extending the 12-hour period for the short-haul exception to the RODS/ELD requirements to 14 hours would change the safety performance of carriers using the short-haul provision?
        b. How specifically would a 14-hour period change your driver or carrier operations as compared to 12 hours?
        c. What would the incremental change be for your operations/business if the exemption was changed to 14 hours? For example, would your operations expand or would your drivers/carriers move from non-exempt status to exempt status. What would be the economic impacts of that incremental change?
        2. Adverse driving conditions.
        a. Is there adequate flexibility in the existing adverse driving conditions exception?
        b. How often do you currently utilize the adverse driving conditions exception?
        c. What are the economic impact of the current exception on your driver or carrier operation?
        d. Should the definition of adverse driving conditions be changed?
        e. Should the adverse driving exception apply to the 14-hour work day window, not just the 11-hour driving limit?
        f. How would the above changes affect the economic costs and benefits, and the impacts on safety and fatigue of the adverse driving conditions exception?
        3. 30-minute break.
        a. If the 30-minute rest break rule did not exist, would drivers obtain adequate rest breaks throughout a daily driving period to relieve fatigue?
        b. Are there alternatives to the 30-minute rest break that would provide additional flexibility to drivers while achieving the safety benefits goal of the current 30-minute break?
        c. If a rest break is retained, should it be taken off-duty or on-duty while the driver is not driving?
        d. How does the 30-minute rest break impact the efficiency of operations from a driver's or a carrier's perspective?
        e. How would your suggestions impact the costs and benefits of the 30-minute break?
        4. Split-sleeper berth.
        a. FMCSA has announced a proposed flexible sleeper berth pilot program. Beyond the information that will be collected in the pilot program, do you have any information that would support changing the current requirements?
        b. Are there alternatives that would make the sleeper berth options more effective or less costly?
        c. How often do you use the sleeper berth option currently; how would this change with your suggested regulatory alternatives?
        d. What cost impacts and safety benefits would result from different split sleeper berth options?
        5. OOIDA Petition.
        a. What specifically would change about your driver/carrier operations by extending the 14-hour driving window?
        b. Is there a likely increase in safety risk from extending the 14-hour driving window? For example, would altering the current rule allowing 14 hours on duty and 10 hours off duty interfere with drivers' circadian rhythm? Could driver health be affected?
        c. Would a potential increase in safety risk be lessened by the requirement that all the additional time beyond 14 hours must be off-duty time?

        d. Would allowing OOIDA's request for an extended break during the work day improve safety by allowing drivers to increase the total amount of off-duty time during and immediately following the work from 10 hours and 30 minutes to 13 hours, without reducing the maximum driving time available within 14-hour window?
        e. Are there other flexibilities or other non-safety benefits that could be realized if the 14-hour window is extended?
        6. TruckerNation Petition.
        a. Is there a likely increase in safety risk from eliminating the consecutive 14-hour driving window? For example, would the absence of a limit on the length of the work shift—the time between the driver coming on duty after accumulating the minimum of 10 hours off-duty and the driver being prohibited from driving—combined with splitting the required 10 consecutive hours off-duty into a number of segments, interfere with drivers' circadian rhythm? Could driver health be affected? Please provide data on the costs and benefits of this approach.
        b. Are there other flexibilities or other non-safety benefits that could be realized if the 14-hour window is eliminated?

          Issued under authority delegated in 49 CFR 1.87 on: August 21, 2018.
          Raymond P. Martinez,
          Administrator.

      [FR Doc. 2018-18379 Filed 8-21-18; 4:15 pm]
      BILLING CODE 4910-EX-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        45 CFR Part 46
        RIN 0940-AA06
        Institutional Review Boards: Registration Requirements

          AGENCY:
          Office of Public Health and Science, HHS.

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:
          The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), is proposing to require registration of institutional review boards (IRBs) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP. The registration information would include contact information, approximate numbers of active protocols involving research conducted or supported by HHS, accreditation status, IRB membership, and staffing for the IRB. The proposed registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP. Under the current OHRP IRB registration system, the submission of certain information is required by the existing HHS human subjects protection regulations, and certain other information may be submitted voluntarily. A request for the approval of this collection of information requirement will be submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with the proposed IRB registration requirements of the Food and Drug Administration (FDA), and creating a single HHS IRB registration system. FDA simultaneously is publishing a proposed rule regarding FDA IRB registration requirements.

          DATES:
          You may submit written or electronic comments on this proposed rule, RIN number 0940-AA06, by October 4, 2004.

          ADDRESSES:
          You may submit comments by any of the following methods:
          • Federal eRulemaking Portal: http:www.regulations.gov. Follow the instructions for submitting comments.
          • E-mail: irbregistrationohrp@osophs.dhhs.gov.

          • Fax: 301-402-2071.
          • Mail to: Irene Stith-Coleman, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
          • Hand Delivery or Courier to: Irene Stith-Coleman, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852
          Comments received within the comment period will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of this notice, at the above address on Monday through Friday of each week from 8:30 a.m. to 4 p.m.

          FOR FURTHER INFORMATION CONTACT:

          Irene Stith-Coleman, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 301-402-7005 or by e-mail to: (istithco@osophs.dhhs.gov).

        SUPPLEMENTARY INFORMATION:

        I. Introduction
        IRBs are boards, committees, or groups formally designated by an institution to review, approve, and have continuing oversight of research involving human subjects. An IRB's primary purpose during such reviews is to ensure the protection of the rights and welfare of human research subjects. The HHS regulations regarding the protection of human research subjects, which address the appropriate role of IRBs in helping to ensure this protection, are found at 45 CFR part 46.
        In 1998, the HHS Office of Inspector General (OIG) issued several reports on IRBs. The OIG sought to identify the challenges facing IRBs and to make recommendations on improving Federal oversight of IRBs. One recommendation was that all IRBs should 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 before they result in “serious transgressions.” (Ref. 1, pp. 20 and 21).
        After reviewing OIG's recommendation, OHRP concluded that IRB registration would serve several important goals. IRB registration would enable OHRP to: (1) Identify more precisely those IRBs reviewing research conducted or supported by HHS under an assurance of compliance approved for federalwide use by OHRP; (2) keep an accurate, up-to-date list of IRBs; (3) send educational information and other information to IRBs, increasing the efficiency of OHRP educational and outreach efforts; and (4) help OHRP identify IRBs that are subject to HHS regulations for monitoring and oversight purposes.

        In December 2000, OHRP initiated a process for registering IRBs. This IRB registration system was designed to collect information required under the HHS human subjects protection regulations at 45 CFR 46.103(b)(3). That regulatory provision requires institutions that are engaged in human subjects research conducted or supported by HHS to file with OHRP an assurance of compliance with the HHS human subjects protection regulations. Under 45 CFR 46.103(a), other Federal Department or Agency heads shall accept an assurance on file with HHS that is approved for federalwide use by OHRP, and that is appropriate for the research in question. Among other things, assurances of compliance must include information on the institution's designated IRB, and a list of IRB members identified by name, earned degrees, representative capacity, experience, and any employment or other relationship with the institution, 45 CFR 46.103(b)(2),(3). The IRB registration system also was designed to collect additional information, to be provided voluntarily by institutions or IRBs, regarding the accreditation status of the institution or IRB organization, 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. The current OHRP IRB registration form can be accessed at: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/regirb.rtf.

        OHRP now proposes to require that any IRB designated under an assurance of compliance approved for federalwide use by OHRP that reviews human subjects research conducted or supported by HHS submit most of the information listed on the IRB registration form that is currently used by OHRP. By requiring IRBs to provide such information, OHRP IRB registration requirements will become substantially consistent with requirements for IRB registration that are simultaneously being proposed by FDA elsewhere in this issue. OHRP and FDA plan to operate a single registration system for HHS in which all IRBs that review research conducted or supported by HHS or clinical investigations regulated by FDA can be registered. The HHS IRB registration system will be operated at a single Internet site on the OHRP Web site.
        OHRP currently posts all registered IRBs on its Web site, including the name and location of the organization operating the IRB(s), called the IRB organization, and the name and location of each IRB. Numbers are assigned to the IRB organization and each IRB is given a unique IRB registration number. An institution submitting an assurance includes the IRB registration number for each IRB designated under its assurance, thereby eliminating the need for multiple submissions of the same information to OHRP.
        The Privacy Act does not apply to the information contained in the IRB registration database. OHRP will not be retrieving information about individuals from this Internet site by name or other individual identifier. Therefore, this Internet site will not be a “system of records” that would be subject to the requirements of the Privacy Act of 1974.
        Upon the effective date of the rule, OHRP will continue to post the name and location of each registered IRB and its IRB registration number on the OHRP Web site. All other information collected in the IRB registration, including names of individual IRB members, would be subject to the Freedom of Information Act, and therefore, may be available to the public upon request. Beyond such access to the information, OHRP will maintain the confidentiality of the information submitted with the IRB registration to the extent allowed by law.
        All of the IRB registration information that is submitted to the Internet site will be transferred to a separate server which will not be accessible via the Internet. In this manner, a high level of security can be maintained for the IRB Registration database.
        OHRP will provide browse-only access to the database containing all information collected in the IRB Registration, via a password protected mechanism, to all Federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the “Common Rule,” which HHS has codified as 45 CFR part 46, subpart A.
        II. Description of the Proposed Rule
        The proposed rule would amend the HHS human subjects protection regulations at 45 CFR part 46 by adding subpart F, entitled “Registration of Institutional Review Boards.” The proposed rule would require IRBs that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS.
        1. Who Must Register? (Proposed § 46.601)
        Proposed § 46.601 requires registration of each IRB that is designated by an institution under an assurance of compliance with HHS human subjects protection regulations that has been approved for federalwide use by OHRP, under 45 CFR 46.103(a), and that reviews human subjects research conducted or supported by HHS.

        Proposed § 46.601 also specifies that an individual authorized to act on behalf of the institution or IRB must submit the registration information. The individual may be an IRB member or any other person authorized by the institution, or IRB, to submit the registration information.

        2. What Information Must an IRB Provide When Registering? (Proposed § 46.602)
        Proposed § 46.602 describes the information to be submitted as part of the registration process. The proposal requires IRBs to provide the following information:
        • The name and mailing address of the institution or organization operating the IRB; the name, earned degree, title, mailing address, phone number, fax number, and e-mail address of the senior or head official of that institution or organization who is responsible for overseeing the activities performed by the IRB; and the name, title, telephone number, fax number, and e-mail address of the person providing the registration information must be provided. The senior or head official should not be an IRB member or IRB staff. This information enables OHRP to identify the institution(s) or organization(s) with which the IRB is affiliated. Information about the senior or head official of the institution enables OHRP to contact that person directly if significant issues or problems arise that involve or could involve the institution, and to forward educational information to that person. Information about the contact person enables OHRP to contact that person directly on routine issues, forward information, and send electronic mail to the contact person.
        • The IRB number, registration name and address; the name, earned degree, title, area of specialty, affiliation, gender, telephone, fax, e-mail address, and mailing address of the IRB chairperson; and an IRB roster that includes the names, earned degrees, gender, area of specialty and affiliation of each voting (including the IRB chairperson) and alternate IRB members must be provided. Collection of this information is consistent with the requirements of 45 CFR 46.103(b)(3) and 46.107(a), and helps OHRP to contact the IRB chairperson quickly, if necessary, on important issues, to send educational information and electronic mail, and to confirm that IRB membership meets the minimum regulatory requirements.
        • The approximate number of active protocols undergoing initial and continuing review; the approximate number of active protocols supported by HHS; and the approximate number of full time positions devoted to the IRB's administrative activities. In this proposal, “active protocol” would mean any protocol or study for which an IRB conducted an initial review or a continuing review during the preceding calendar year.
        The proposal would not require an institution or IRB organization to report a specific number of protocols; instead, registration would indicate the range of the number of protocols reviewed in the preceding calendar year. The proposal would consider a “small” number of protocols to be 1 to 25 protocols, “medium” to be 26 to 499, and “large” to be 500 or more protocols. This information will enable OHRP to determine how active an IRB is and to assign its quality improvement, educational, and compliance oversight resources based on an IRB's activity level. For example, scheduling the site of an OHRP national workshop could involve assessment of the volume of research conducted by an institution in a potential locale. Furthermore, HHS regulations for the protection of human subjects at 45 CFR 46.103(b)(2) require that assurances of compliance applicable to HHS conducted or supported research include the designation of one or more IRBs for which, among other things, provisions are made for meeting space and sufficient staff to support the IRB's review and record keeping duties. In OHRP's experience, the number of FTEs and the volume of research are useful parameters for assessing whether an IRB has sufficient staff, as required by HHS regulations for the protection of human subjects at 45 CFR 46.103(b)(2).
        • An indication as to whether the assured institution or IRB organization is currently accredited by a human subjects protection program accrediting organization, and if so, the date of its last accreditation and the name of that accrediting organization must be provided. OHRP recognizes that accreditation is a developing concept, so information on accreditation will help OHRP to evaluate the extent and value of IRB accreditation. OHRP specifically solicits public comment related to the perceived value of collecting information on the accreditation status of IRBs.
        In addition, the IRB registration process includes information required by FDA under its proposed rule: the number of active protocols (small, medium, or large) involving FDA-regulated products reviewed (both initial reviews and continuing reviews); and a description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in active protocols that the IRB reviews.
        Due to statutory and regulatory differences between OHRP and FDA, the Internet registration site may request more information from IRBs reviewing research conducted or supported by HHS than those reviewing clinical investigations regulated by FDA that are not conducted or supported by HHS. In those instances where the registration site would seek more information than FDA would require under its proposal, the internet site would clarify that IRBs regulated solely by FDA are not required to provide the additional information.
        The proposed rule would not require submission of one element of information that currently is submitted voluntarily. It would not require IRBs to provide information on the approximate number of currently active protocols supported by other Federal departments or agencies. OHRP determined that collection of such information should not be required because the proposed rule would apply only to IRBs that are designated under an OHRP-approved assurance of compliance and that review research conducted or supported by HHS.
        3. When Must an IRB Register? (Proposed § 46.603)
        Proposed § 46.603 requires IRBs to register when designated under an assurance approved for federalwide use by OHRP. Specifically, the proposal would require an IRB to register when any institution files with OHRP an assurance of compliance with the HHS human subjects protection regulations under 45 CFR 46.103(a), that is to be approved for federalwide use by OHRP, and that designates the IRB to review human subjects research conducted or supported by HHS. IRB registration will become effective on the date that OHRP lists the IRB registration on its website.

        To show how this would work, assume that an institution is engaged, for the first time, in human subjects research conducted or supported by HHS. The institution then would be subject to the HHS human subjects protection regulations, and would be required to file an assurance of compliance with those regulations under 45 CFR 46.103(a). Designation of an IRB is part of that assurance process. If the institution's assurance is submitted to, and approved for federalwide use by, OHRP, the IRB(s) designated under the assurance would have to register with HHS if not previously registered. Further, if the institution designates an additional IRB under its assurance, the additional IRB must first register and the assurance must be updated to include the new IRB. As discussed under item 5 below, OHRP will continue to recognize IRB registrations that were completed prior to the effective date of the rule, and will give such IRBs 90 days from the effective date of the rule to submit to OHRP revisions to the existing registration information, if necessary, to meet additional requirements of the proposed rule.
        Proposed § 46.603 also requires IRBs to renew their registrations every 3 years. Requiring IRBs to renew their registrations periodically helps to ensure that HHS information remains current.
        4. Where Can an IRB Register? (Proposed § 46.604)
        Proposed § 46.604 directs IRBs to register at a specific HHS Internet site or, if the institution or IRB organization lacks the ability to register electronically, to send registration information to OHRP's mailing address. Although Internet registration may be easier and faster than written registration, OHRP cannot determine how widespread Internet access is among IRBs. Thus, OHRP also allows for written registration in addition to Internet registration.
        5. How Does an IRB Revise Its Registration Information? (Proposed § 46.605)
        Under proposed § 46.605, if contact or IRB membership registration information changes, the IRB must revise its registration information within 90 days of the change. All information involving changes other than changes in an IRB contact, an IRB chairperson or the IRB roster only need to be updated at the time of the 3 year renewal pursuant to proposed § 46.603. For example, if an IRB selects a new chairperson, the IRB, under proposed § 46.605, would revise its registration information within 90 days after the new chairperson's selection.
        Proposed § 46.605 also considers an assured institution's or IRB organization's decision, to disband a registered IRB, or to stop reviewing research conducted or supported by HHS, to be a change that must be reported to HHS within 30 days. Requiring an IRB to report to HHS when it has disbanded or discontinued reviewing research conducted or supported by HHS will enable OHRP to stop sending educational information to the IRB and ensure that the HHS IRB registration system is accurate and up to date. More importantly, funding agencies that rely on the HHS IRB registration system will then be able to rely on the IRB registration website for a current, accurate list of designated IRBs for an institution.
        OHRP will continue to recognize IRB registrations that were completed prior to the effective date of the rule, but will give IRBs that previously did not include complete information 90 days from the effective date of the rule to provide such information. That is, IRBs that chose not to provide registration information that previously was considered voluntary would be expected to complete the registration form and provide that information within 90 days of enactment of the rule.
        Revised registration information may be submitted electronically to OHRP or, if an IRB lacks Internet access, in writing, to OHRP's mailing address.
        6. What Happens if an IRB Does Not Register or Fails To Revise its Registration Information?
        An IRB cannot be designated under an assurance of compliance approved for federalwide use by OHRP if it fails to register. For example, if an assurance submitted to OHRP for approval lists only one IRB that reviews research conducted or supported by HHS, and that IRB fails to register, OHRP would not approve that assurance. If an assurance approved for federalwide use by OHRP lists two or more IRBs that will review research conducted or supported by HHS, and one IRB fails to register, OHRP could issue a restricted approval of the assurance so that the unregistered IRB may not review HHS-conducted or supported research.
        If an IRB designated under an assurance approved for federalwide use by OHRP fails to appropriately revise its registration information in accordance with § 46.605 of the proposed rule, OHRP could restrict or revoke its approval of the assurance. For example, if an IRB fails to appropriately revise its registration information in accordance with § 46.605 of the proposed rule, and the IRB is reviewing human subjects research conducted or supported by HHS, OHRP could take appropriate action under the institution's assurance and OHRP's compliance oversight policies and procedures. OHRP believes that the proposed registration requirement is both simple and straightforward, so it does not expect that many institutions or IRB organizations will refuse or fail to register or revise its registration information.
        III. Implementation

        OHRP intends to make any final rule based on this proposal effective within 60 days after the final rule is published in the Federal Register. Initial registration with all required information and required revisions to registration must be submitted within 60 days of the effective date of the rule. IRBs voluntarily may register before the required registration deadline.
        IV. Legal Authority

        Section 491 of the Public Health Service Act authorizes the Secretary, by regulation, to require each entity which applies for a grant, contract, or cooperative agreement under the Act for any project or program which involves the conduct of biomedical or behavioral research involving human subjects to submit assurances satisfactory to the Secretary that it has established an IRB to review research conducted at or supported by the entity in order to protect the rights of the human subjects (see 42 U.S.C. 289(a)). Section 491 of the Public Health Service Act also authorizes the Secretary to establish a program under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately (see 42 U.S.C. 289(b)). These authorities are delegated to OHRP (see 67 FR 10216-18, March 6, 2002).
        By requiring IRB registration, the proposed rule would, if finalized, aid in the efficient implementation of the Public Health Service Act's provisions regarding assurances and providing guidance and education to IRBs involved in human subjects research conducted or supported by HHS. Moreover, by requiring IRBs to register, the proposed rule would enable OHRP to contact IRBs more quickly and efficiently on various issues, such as new regulatory requirements or policies or other matters related to the conduct of human subjects research. OHRP concludes that it has sufficient legal authority to issue the proposed rule.
        V. Economic Impact Analysis

        OHRP has examined the impact of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities.
        Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation).
        The proposed rule is consistent with the principles set forth in Executive Order 12866 and these two statutes. As explained below, the proposed rule is not an economically significant regulatory action as defined in Executive Order 12866 and does not require a Regulatory Flexibility Act Analysis. The Unfunded Mandates Reform Act does not require HHS to prepare a statement of costs and benefits for the proposed rule because the proposed rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is approximately $110 million.
        The proposed rule would require IRBs designated under an assurance of compliance approved for Federalwide use by OHRP to register with HHS. The information sought through the registration process would be minimal, consisting largely of names and addresses for a contact person, the institution operating the IRB (if an institution exists), the senior or head officer of the institution who is responsible for overseeing the activities performed by the IRB, the IRB chairperson, and limited information about the IRB members' gender, earned degree, scientific or nonscientific specialty, and affiliation. The registration would also indicate whether the IRB reviews a “small,” “medium,” or “large” number of research protocols. IRBs would also indicate whether they are accredited and, if so, identify the accrediting body or organization. OHRP estimates that initial IRB registration may require 1 hour to complete. If the average wage rate is $40 per hour, this means that each IRB would spend $40 for an initial registration ($40 per hour x 1 hour per initial registration).
        OHRP estimates that renewal of registration would require less time, especially if the IRB is only verifying existing information. If renewal registration requires 30 minutes, then the cost of renewal registration to each IRB would be approximately $20 ($40 per hour x 0. 0.5 hour per renewal registration).
        Revising an IRB's registration information would probably involve costs similar to renewal registration costs. If the revision requires 30 minutes, then the cost of revising an IRB's registration information would be approximately $20 per IRB.
        Additionally, assuming that the maximum number of IRBs that would be subject to the proposed rule would be 5,000: 2,000 initial registrations; 1,000 renewals; and 2,000 revisions, the proposed rule, if finalized, would result in a 1-year expenditure of $140,000 (2,000 x $40 = $80,000; 1,000 x $20 = $20,000; and 2,000 x $20 = $40,000).
        Given the minimal registration information that would be required and the low costs associated with registration, this proposed rule is not a significant regulatory action, and OHRP certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. The proposal is not a significant regulatory action under Executive Order 12866 and does not require a Regulatory Flexibility Act analysis.
        Because the total expenditure under the rule will not result in a 1-year expenditure of $100 million or more, OHRP is not required to perform a cost-benefit analysis under the Unfunded Mandates Reform Act.
        VI. Environmental Impact
        OHRP has determined that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
        This proposed rule contains information collection requirements that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). OHRP submitted the IRB Registration form to OMB for approval pursuant to the Paperwork Reduction Act prior to issuing this proposed rule.

          Title: Institutional Review Boards: Registration Requirements.

          Description: The proposed rule would require institutions and IRB organizations to register their designated IRBs with HHS.

          Description of Respondents: Businesses and individuals.

        The estimated annual burden associated with the current information collection is 3,500 hours. The estimated annual burden associated with the information collection requirements of this proposed rule is 3,500 hours. One element of information currently collected would not be collected after adoption of the proposed rule (i.e., information on the approximate number of active protocols supported by other Federal departments or agencies).

          Table 1.—Estimated Annual Reporting Burden (Current)

            45 CFR section
            No. of respondents
            Frequency of responses
            Total annual responses
            Hours per response
            Total hours

            § 46.603 (initial registration)
            2,000
            1
            2,000
            1
            2,000

            § 46.603 (re-registration)
            0
            0
            0
            0
            0

            § 46.605 (revisions)
            2,090
            1
            2,090
            0.5
            1045

            Total

            3,045

          Table 2.—Estimated Annual Reporting Burden (Proposed Rule)

            45 CFR Section
            No. of respondents
            Frequency of responses
            Total annual responses
            Hours per response
            Total hours

            § 46.603 (initial registration)
            2,000
            1
            2,000
            1
            2,000

            § 46.603 (re-registration)
            1,000
            1
            1,000
            0.5
            500

            § 46.605 (revisions)
            2,000
            1
            2,000
            0.5
            1,000

            Total

            3,500

        There are no capital costs or operating and maintenance costs associated with this collection of information.
        OHRP's estimates are based on the following considerations. According to a 1998 OIG report, there are 3,000 to 5,000 IRBs in the United States, and most are associated with hospitals and academic centers (Ref. 1, p. 3). While not all IRBs review human subjects research conducted or supported by HHS or otherwise covered under an assurance approved by OHRP, the agency, for purposes of the Paperwork Reduction Act, will use 5,000 as the maximum number of IRBs subject to the proposed rule. Additionally, because the proposed rule would require basic information about an IRB (such as names and addresses) and because registration would, in most cases, be done electronically, OHRP assumes that registration currently takes, and will take (under the proposed rule), only 1 hour per IRB for new registrations, and one half hour per IRB for revisions or renewals.
        Thus, the total burden hours would be 2,000 for new registrations per year (2,000 IRBs × 1 hour per IRB).
        Renewal registration and revisions to existing registration information should require less time than initial registration. OHRP assumes that renewal registration and revisions currently takes, and will take (under the proposed rule), only 30 minutes per IRB for a total of 500 burden hours for renewals (1,000 IRBs × 0.5 hour = 500) and 1,000 for revisions (2,000 IRBs hour × .5 hour) = 1,000 hours.

        A notice seeking public comments on the existing IRB registration requirements was published in the Federal Register on April 19, 2002 (67 FR 19438). OHRP is inviting additional comments on both the current information collection and the proposed information collection.

        Request for Comment: In compliance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for an agency to provide opportunity for public comment on current information collections and also on proposed information collection projects, OHRP invites comments on: (1) Whether the collection of information is necessary for the proper performance of OHRP's functions, including whether the information will have practical utility; (2) the accuracy of OHRP's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. In this same issue of the Federal Register, OHRP also is soliciting public comment on the information collection in the Federalwide Assurance (FWA).
        Interested persons are requested to send comments regarding the current and proposed information collections by August 5, 2004 to the following:

        Department of Health and Human Services, Naomi Cook, OS/ASBTF/OIRM/OIRM/OITP, IT Desk Officer/GPEA, 200 Independence Ave., SW., Washington, DC 20201
         and
        Office of Information and Regulatory Affairs, Office of Management and  Budget, fax number (202) 395-6974, Attn: Fumie Yokota.
        VIII. Federalism
        OHRP has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. OHRP has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.
        IX. Request for Comments
        Interested persons may submit to OHRP (see
          ADDRESSES) written or electronic comments regarding this proposal by October 4, 2004.
        X. Reference

        The following reference is available from OHRP through the contact listed above or can be accessed at: http://oig.hhs.gov/oei/ reports/oei- 01-97-00193.pdf.

        1. OIG, HHS, “Institutional Review Boards: A Time for Reform,” June 1998.

          List of Subjects in 45 CFR Part 46
          Health—Clinical research, Medical research, Human research subjects, Reporting and recordkeeping requirements

          Dated: June 2, 2004.
          Cristina V. Beato,
          Acting Assistant Secretary for Health.
          Approved: June 22, 2004.
          Tommy G. Thompson,
          Secretary of Health and Human Services.

        For the reasons set forth in the preamble, it is proposed that 45 CFR part 46 be amended as follows:

          PART 46—PROTECTION OF HUMAN SUBJECTS
          1. The authority citation for 45 CFR part 46 continues to read as follows:

            Authority:
            5 U.S.C. 301; 42 U.S.C.289; 42 U.S.C.300v-1(b).

          2. Subpart F is added to part 46 to read as follows:

              Subpart F—Registration of Institutional Review Boards
              Sec.
              46.601
              Who must register?
              46.602
              What information must an IRB provide?
              46.603
              When must an IRB register?
              46.604
              Where can an IRB register?
              46.605
              How does an IRB revise its registration information?

            Subpart F—Registration of Institutional Review Boards

              § 46.601
              Who must register?
              Each IRB that is designated by an institution under an assurance of compliance approved for federalwide use by the Office for Human Research Protections (OHRP) under § 46.103(a) and that reviews research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must register with HHS. An individual authorized to act on behalf of the institution or IRB must submit the registration information.

              § 46.602
              What information must an IRB provide?
              Each IRB must provide the following information to HHS:
              (a) The name and mailing address of the institution or organization operating the IRB; and the name, earned degree, title, mailing address, telephone number, facsimile number, and electronic mail address of the senior or head official of that institution or organization who is responsible for overseeing activities performed by the IRB;
              (b) The name, title, telephone number, facsimile number, and electronic mail address of the contact person providing the registration information;

              (c) The IRB number, registration name (for an initial registration, OHRP will assign the IRB number and registration name), and address;

              (d) The name, gender, earned degree, title, mailing address, telephone number, facsimile number and electronic mail address of each IRB chairperson;
              (e) An IRB roster that includes the name, gender, degree, scientific or nonscientific specialty, and affiliation of each voting and alternate IRB member, including the chairperson;
              (f) Using the measures “small,” “medium,” and “large,” the approximate number of total active protocols undergoing initial and continuing review; and active protocols supported by HHS. For purposes of this subpart, an “active protocol” is any protocol or study for which an IRB conducted an initial review or a continuing review during the preceding calendar year. A “small” number of protocols is 1 to 25 protocols, “medium” is 26 to 499 protocols, and “large” is 500 protocols or more;
              (g) The approximate number of full time positions devoted to the IRB's administrative activities;
              (h) An indication whether the institution or IRB organization is accredited and, if so, the date of the last accreditation and the name of the accrediting body or organization.

              § 46.603
              When must an IRB register?
              Each IRB must register when designated under an assurance approved for federalwide use by OHRP under § 46.103(a). The registration will be effective for 3 years. Each IRB must renew its registration every three years. Any complete update or renewal that is submitted to, and approved by, OHRP, begins a new 3-year effective period. IRB registration becomes effective when HHS posts that information on its Web site.

              § 46.604
              Where can an IRB register?
              Each IRB may register electronically through [Web site address to be added in the final rule]. If an IRB lacks the ability to register electronically, it must send its registration information, in writing, to OHRP.

              § 46.605
              How does an IRB revise its registration information?
              If registration information regarding an IRB contact, an IRB chairperson or IRB roster changes, the IRB must revise that information within 90 days by submitting any changes in that information. An assured institution's or IRB organization's decision to disband a registered IRB or to discontinue reviewing research conducted or supported by HHS also must be reported within 30 days. All other information changes may be reported when the IRB renews its registration. The revised information may be sent to HHS either electronically or in writing in accordance with § 46.604.

      [FR Doc. 04-14679 Filed 7-2-04; 8:45 am]
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