[Federal Register Volume 69, Number 128 (Tuesday, July 6, 2004)]
[Proposed Rules]
[Pages 40584-40590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14679]


=======================================================================
-----------------------------------------------------------------------

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: [email protected].
     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

[[Page 40585]]

200, Rockville, MD 20852, 301-402-7005 or by e-mail to: 
([email protected]).

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 Sec.  46.601)

    Proposed Sec.  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 Sec.  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.

[[Page 40586]]

2. What Information Must an IRB Provide When Registering? (Proposed 
Sec.  46.602)

    Proposed Sec.  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 Sec.  46.603)

    Proposed Sec.  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

[[Page 40587]]

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 Sec.  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 Sec.  46.604)

    Proposed Sec.  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 Sec.  
46.605)

    Under proposed Sec.  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 Sec.  46.603. For example, if an IRB selects a new 
chairperson, the IRB, under proposed Sec.  46.605, would revise its 
registration information within 90 days after the new chairperson's 
selection.
    Proposed Sec.  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 Sec.  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 Sec.  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

[[Page 40588]]

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)
----------------------------------------------------------------------------------------------------------------
                                      No. of       Frequency of    Total annual      Hours per
         45 CFR section             respondents      responses       responses       response       Total hours
----------------------------------------------------------------------------------------------------------------
Sec.   46.603 (initial                     2,000               1           2,000               1           2,000
 registration)..................
Sec.   46.603 (re-registration).               0               0               0               0               0
Sec.   46.605 (revisions).......           2,090               1           2,090             0.5            1045
                                 -----------------
    Total.......................  ..............  ..............  ..............  ..............           3,045
----------------------------------------------------------------------------------------------------------------


                           Table 2.--Estimated Annual Reporting Burden (Proposed Rule)
----------------------------------------------------------------------------------------------------------------
                                      No. of       Frequency of    Total annual      Hours per
         45 CFR Section             respondents      responses       responses       response       Total hours
----------------------------------------------------------------------------------------------------------------
Sec.   46.603 (initial                     2,000               1           2,000               1           2,000
 registration)..................
Sec.   46.603 (re-registration).           1,000               1           1,000             0.5             500
Sec.   46.605 (revisions).......           2,000               1           2,000             0.5           1,000
                                 -----------------
    Total.......................  ..............  ..............  ..............  ..............           3,500
----------------------------------------------------------------------------------------------------------------


[[Page 40589]]

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 x 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 x 0.5 hour = 500) 
and 1,000 for revisions (2,000 IRBs hour x .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


Sec.  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 Sec.  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.


Sec.  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;

[[Page 40590]]

    (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.


Sec.  46.603  When must an IRB register?

    Each IRB must register when designated under an assurance approved 
for federalwide use by OHRP under Sec.  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.


Sec.  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.


Sec.  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 Sec.  46.604.

[FR Doc. 04-14679 Filed 7-2-04; 8:45 am]
BILLING CODE 4150-36-P