Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2399 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 46 

RIN 0940–AA06 

Office of Public Health and Science; 

Institutional Review Boards: 

Registration Requirements 

AGENCY: Office of Public Health and 

Science, HHS. 

ACTION: Final rule. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

Public Health and Science, Department 

of Health and Human Services (HHS), is 

adding a new subpart E to the HHS 

protection of human subjects 

regulations, which requires institutional 

review boards (IRB) 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. The 

registration information includes 

contact information, approximate 

numbers of all active protocols and 

active protocols involving research 

conducted or supported by HHS, and 

staffing for the IRB. The 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 this final rule, the IRB 

registration system is compatible with 

the IRB registration requirements of the 

Food and Drug Administration (FDA), 

which are simultaneously published as 

a final rule in this issue of the Federal 

Register, allowing the operation of a 

single HHS IRB registration system. 

DATES: This rule is effective July 14, 

2009. This protracted effective date is 

necessary to allow refinement of the 

electronic registration system so that it 

corresponds to this final rule and the 

FDA’s final rule, and obtain Office of 

Management and Budget (OMB) review 

and approval for the information 

collection requirements of this rule. 

Initial registration with all required 

information must be submitted within 

60 days of the effective date of the rule, 

by September 14, 2009. For any IRB 

currently registered with OHRP, the 

institution or organization operating the 

IRB must submit all information 

required under this rule by the threeyear expiration date previously assigned 

by OHRP or within 90 days of any 

changes regarding the contact person 

who provided the IRB registration 

information or the IRB chairperson. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, PhD, Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852, telephone (240) 453–6900, email irene.stith-coleman@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

HHS, through OHRP, regulates 

research involving human subjects 

conducted or supported by HHS in 

regulations codified at 45 CFR part 46. 

The HHS protection of human subjects 

regulations address the appropriate role 

of IRBs in the human subject research 

enterprise. IRBs are boards, committees, 

or groups formally designated by an 

institution to conduct initial and 

continuing review 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. 

OHRP has been operating a system of 

IRB registration since December 2000, 

which was initiated in response to a 

1998 HHS Office of Inspector General 

(OIG) recommendation that all IRBs 

register with the Federal government on 

a regular basis as part of an effort to 

develop a more streamlined, 

coordinated, and probing means of 

assessing IRB performance and to 

enhance the Federal government’s 

ability to identify and respond to 

emerging problems. 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 (i.e., a Federalwide 

Assurance [FWA]); (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) identify IRBs 

that are subject to HHS regulations for 

monitoring and oversight purposes. 

The OHRP IRB registration system 

was designed to collect information 

required under the HHS human subjects 

protection regulations at 45 CFR 46.103. 

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. The only type of 

assurance currently accepted by OHRP 

is an FWA. Among other things, 

assurances of compliance must include 

information on the institution’s 

designated IRB(s), 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 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. 

On July 6, 2004, OHRP published in 

the Federal Register a Notice of 

Proposed Rulemaking (NPRM) seeking 

public comment on changes to the 

current IRB registration system 

administered by OHRP (69 FR 40584). 

OHRP proposed to amend the HHS 

human subjects protection regulations at 

45 CFR part 46 by adding subpart F, 

entitled ‘‘Registration of Institutional 

Review Boards.’’ In the new subpart F, 

OHRP proposed 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, including the information 

that previously was provided on a 

voluntary basis, listed on the IRB 

registration form that is currently used 

by OHRP. By requiring IRBs to provide 

such information, OHRP IRB 

registration requirements would become 

substantially consistent with 

requirements for IRB registration that 

were simultaneously proposed by FDA 

(69 FR 40556). OHRP and FDA 

proposed to use a single registration 

system, accessible on the OHRP Web 

site, in which all IRBs that review 

research conducted or supported by 

HHS or clinical investigations regulated 

by FDA can be registered. 

The proposed subpart F specifically 

addressed who must register an IRB, 

what information an IRB must provide 

when registering, when an IRB must 

register, where an IRB can register, and 

how an IRB can revise its registration 

information. 

In preparing the final rule, HHS has 

changed the designation of proposed 

subpart F to subpart E and changed the 

numbering of the provisions from 

§§ 46.601–605 to §§ 46.501–505. 

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2400 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

II. Comments 

Discussion of Individual Comments 

During the public comment period 

that ended October 4, 2004, the 

Department received 13 public 

comments on the proposed rule from 

interested parties. In general, the 

comments were supportive of IRB 

registration, although some commenters 

disagreed with specific aspects of the 

proposed rule. The comments are 

summarized as follows: 

1. What information must an IRB 

provide when registering? (Proposed 

§ 46.602) 

Proposed § 46.602 described the 

information to be submitted as part of 

the registration process. Specific 

comments were received on the 

following proposed data elements 

required for registration. 

IRB Roster 

OHRP proposed to collect an IRB 

roster that includes the names, earned 

degrees, gender, area of specialty and 

affiliation of each voting member 

(including the IRB chairperson) and 

alternate IRB members. 

One commenter stated that the value 

or utility of collecting information about 

the IRB roster is not clear and that the 

collection may be quite burdensome. 

OHRP notes that the collection of IRB 

roster information by HHS for each IRB 

that is designated on an OHRP-approved 

FWA already is required by 45 CFR 

46.103(b)(3), and thus has decided to 

delete this requirement from the final 

rule as unnecessarily duplicative. 

However, the IRB registration form will 

continue to include IRB roster 

information as part of the IRB 

registration process since this 

information is required by 45 CFR 

46.103(b)(3). 

Approximate Number of Total Active 

Protocols 

OHRP proposed to require submission 

of the approximate number of total 

active protocols undergoing initial and 

continuing review and the approximate 

number of active protocols supported by 

HHS. The proposal would have required 

identification of the range of the number 

of protocols reviewed in the preceding 

calendar year. A ‘‘small’’ number of 

protocols would be 1 to 25 protocols, 

‘‘medium’’ 26 to 499 protocols, and 

‘‘large’’ 500 or more protocols. OHRP 

explained that this information will 

enable it 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. 

One commenter asserted that this 

collection poses an unnecessary 

reporting burden by going beyond the 

information needed to meet the 

registration requirements, and strongly 

recommended that OHRP limit its data 

collection to elements that support 

regulatory requirements. This 

commenter argued that the proposed 

data collection will not provide OHRP 

with information that assists in the 

constructive assessment of an 

institution’s IRB activity, and, as a 

consequence, has limited value. The 

commenter noted that, for example, 24 

cancer studies will most likely generate 

a significantly greater volume of work 

for an IRB than 500 social or statistical 

data analyses—many of the latter of 

which will be reviewed under expedited 

review procedures. 

Two other commenters expressed 

concern about this information 

collection. One stated that, given the 

variety of protocols that are being 

performed at any large research 

university and the different oversight 

workloads that varying protocols 

require, such a crude measure might 

lead to erroneous interpretation of the 

registration data. This commenter 

asserted that, at a minimum, such data 

should be accompanied by a disclaimer 

to avoid misunderstanding, but that 

OHRP may want to reconsider the 

necessity and validity of such 

information. The second commenter 

said that it is unclear how useful or 

accurate such data would be in light of 

the following factors: The varying 

complexity of IRB review and protocoldriven research activity (e.g., social and 

behavioral, biomedical, phase 1, 2, or 3 

studies, gene therapy); the level of IRB 

review (i.e., review at a convened 

meeting or expedited review process) 

required for different types of research 

protocols (e.g., chart reviews, 

interventions, survey research, 

continuation review, etc.); and the 

frequent and daily changes in the 

number of protocols reviewed by an 

IRB. The commenter recommended that 

this information collection be an 

optional question. 

Another commenter questioned 

whether research volume per se is an 

accurate measure of the workload of an 

IRB. Acknowledging and appreciating 

that OHRP did not propose that 

institutions be required to supply 

specific numbers of active protocols 

undergoing initial and continuing 

review each year, this commenter had 

no objection to the proposal of 

numerical ranges that can be selected by 

registrants to describe their activity. 

However, the commenter urged that the 

information be interpreted carefully and 

cautiously in light of the importance of 

OHRP’s proposed uses of the 

information collected. 

Another commenter supported this 

information collection but encouraged 

OHRP to consider redefining the ranges 

as small 1–99, medium 100–499, large 

500–1,999, and very large 2,000 or more. 

The commenter noted that there are a 

substantial number of organizations that 

oversee thousands of protocols and thus 

operate quite differently from those that 

oversee 500 protocols; further, there 

appears to be a small number of 

organizations with fewer than 25 

protocols, and organizations with very 

few protocols often rely upon an IRB 

operated by another organization rather 

than form their own IRB. 

After careful consideration of all 

comments, OHRP will retain this 

information requirement in the final 

rule for the reasons stated in the NPRM: 

This information will provide insight 

into an IRB’s activity level and allow 

OHRP to more effectively assign its 

quality improvement, educational, and 

compliance oversight resources. 

However, given that the proposed 

protocol ranges were artificial, we have 

revised the rule to eliminate the 

‘‘small,’’ ‘‘medium’’, and ‘‘large’’ ranges. 

Instead, the final rule requires 

submission of an approximate number 

of all active protocols and the 

approximate number of active protocols 

conducted or supported by HHS. For the 

purpose of the final rule, an ‘‘active 

protocol’’ is any protocol or study for 

which an IRB conducted an initial 

review or a continuing review at a 

convened meeting or under an 

expedited review procedure during the 

preceding twelve months. OHRP will 

utilize this data cautiously and does not 

intend to use this data to make 

presumptive or sweeping 

determinations regarding an 

institution’s human subject protection 

program. 

Approximate Number of Full-Time 

Equivalent Positions 

OHRP proposed to require submission 

of the approximate number of full-time 

equivalent positions (FTEs) devoted to 

the IRB’s administrative activities. 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 recordkeeping duties. In 

OHRP’s experience, the number of FTEs 

compared to the volume of research is 

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one useful parameter 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). 

Two commenters objected to this 

proposed information requirement. One 

recommended that these data not be 

included in the registry, stating that 

there is no standard measure for IRB 

staffing and no formula for allocation of 

personnel to administer an IRB; the 

nature of the protocols reviewed— 

biomedical or social and behavioral 

sciences—has a direct impact on staffing 

decisions; and information on the 

number of full-time IRB staff positions 

is of limited value in assessing the 

institution’s commitment to human 

subject protection. The commenter 

asserted that this collection poses an 

unnecessary reporting burden by going 

beyond the information needed to meet 

the registration requirements, and 

strongly recommended that OHRP limit 

its data collection to elements that 

support regulatory requirements. The 

commenter also stated that the request 

for information about the number of 

staff devoted to the IRB does not 

strengthen the value of the protocol 

data; and that as with the approximation 

of active protocols, the types of 

protocols reviewed and managed by the 

IRB staff—biomedical or social and 

behavioral sciences—have a direct effect 

on the allocation of resources. The 

second commenter urged that this 

information be interpreted carefully and 

cautiously in OHRP’s determinations of 

whether or not an institution has made 

provisions for meeting space and 

sufficient staff to support the IRB’s 

review and record keeping duties. 

OHRP finds that collecting 

information on the number of FTEs 

allocated to IRB administrative activities 

poses little if any burden on institutions 

and would be helpful in OHRP’s 

assessment of whether an IRB has 

sufficient staff, and therefore, OHRP has 

retained this requirement in the final 

rule. OHRP will utilize this data 

cautiously and intends neither to use 

this information as the only parameter 

for measuring regulatory compliance 

with 45 CFR 46.103(b)(2), nor to use this 

data to make presumptive or sweeping 

determinations regarding an 

institution’s human subject protection 

program. OHRP has no intention of 

using this data to develop a formula for 

assessing the adequacy of IRB resources. 

Accreditation Status 

OHRP proposed to require submission 

of information regarding whether the 

institution or organization registering an 

IRB currently is accredited by a human 

subjects protection program accrediting 

organization, and if so, the date of its 

last accreditation and the name of the 

accrediting organization. OHRP stated 

that because accreditation is a 

developing concept, information on 

accreditation will help OHRP to 

evaluate the extent and value of IRB 

accreditation, and specifically solicited 

public comment related to the perceived 

value of collecting information on the 

accreditation status of IRBs. 

Four commenters endorsed the 

collection of accreditation status 

information. Of these, two urged OHRP 

to use the accreditation of the 

institution, organization, or human 

research protection program as the unit 

of measure rather than IRB 

accreditation. 

Four commenters objected to the 

proposed collection of accreditation 

status information. Two of these 

commenters indicated that the 

accreditation process is relatively new 

and noted that the names of accredited 

institutions and organizations are 

publicly accessible at sites that will 

present more up-to-date information 

than would be available in the HHS IRB 

registration database. One of the 

objecting commenters stated that the 

information may not be accurate, and 

another noted that accreditation has 

shown no proven benefit and no one set 

of accreditation standards has been 

developed or accepted. 

In response to these comments, OHRP 

has decided to eliminate the 

requirement for reporting accreditation 

status from the final rule. Because 

similar information is publicly 

accessible, OHRP has determined that 

collection of this information through 

the IRB registration process is 

unnecessary. 

Other Data Elements 

One commenter noted that the data 

required for registration fails to include 

a parameter that would monitor whether 

IRB members have experience that 

would contribute to an adequate review 

of research studies involving children. 

The commenter requested that proposed 

§ 46.602(e) be modified to require an 

indication of whether each IRB member 

has child health care and research 

expertise, and that proposed § 46.602(f) 

be expanded to include an estimate of 

the number of protocols an IRB 

reviewed that involved children. OHRP 

finds that the collection of such 

information is not necessary to further 

its goals of ensuring consistency with 

the requirements of 45 CFR 46.103(b)(3) 

that pertain to IRB composition. 

One commenter suggested that the 

information collected from IRBs include 

a sense of the scope of vulnerable 

populations included in the research 

protocols, such as children, pregnant 

women, the elderly, and prisoners. 

OHRP finds that the collection of such 

information is not necessary to further 

the stated goals of the IRB registration 

system. 

2. Where can an IRB register? (Proposed 

§ 46.604) 

Proposed § 46.604 directed IRBs to 

register at an 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. 

One commenter expressed pleasure 

that IRB registration may be performed 

online, greatly easing the compliance 

burden associated with such a 

requirement. OHRP agrees that online 

registration simplifies the IRB 

registration process and expects that 

nearly all institutions or IRB 

organizations have the capability to 

register electronically. The final rule has 

been modified to now require that each 

IRB must be registered electronically 

unless an institution or organization 

lacks the ability to register its IRB(s) 

electronically. If an institution or 

organization lacks the ability to register 

an IRB electronically, it must send its 

IRB registration information in writing 

to OHRP. 

3. How does an IRB revise its 

registration information? (Proposed 

§ 46.605) 

Proposed § 46.605 required that 

changes in the IRB contact, chairperson, 

or roster information be updated in the 

registry within 90 days. Whenever the 

electronic system is used to update or 

revise such information, the system 

instructs that all data on the IRB 

registration form be verified. 

Proposed § 46.605 also considered 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. 

One commenter expressed concern 

about the requirement for reporting the 

closure of an IRB within 30 days, noting 

that the closure process may take longer 

than 30 days and that imposition of this 

requirement would put an undue 

burden on IRBs and the supporting 

institutions. In response to this 

comment, OHRP has added clarifying 

language to the final rule (now § 46.505) 

to indicate that an institution’s or 

organization’s decision to disband a 

registered IRB designated under an 

FWA must be reported to OHRP within 

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30 days of permanent cessation of the 

IRB’s review of HHS-conducted or 

supported research. 

OHRP notes that § 46.505 of the final 

rule has been modified from the 

proposed § 46.605 to delete the 

requirement that IRB roster changes 

must be submitted within 90 days, 

because 45 CFR 46.103(b)(3) already 

requires that changes in IRB roster 

information be reported to OHRP. 

4. General Comments 

Nine commenters specifically 

commented in support of the concept of 

IRB registration. 

One commenter requested that FDA 

and OHRP maintain one common 

registration site that will automatically 

include currently registered IRBs and 

allow them to retain their currently 

assigned numbers. OHRP notes that 

such a common registration site has 

been created. 

One commenter urged that the 

information required from registered 

IRBs be the same for both FDA and 

OHRP. OHRP finds that, because of the 

differing statutory and regulatory 

authorities of FDA and OHRP to collect 

IRB registration information, the 

information required from registered 

IRBs is not the same for both agencies. 

However, OHRP notes that § 46.502 of 

the final rule has been modified from 

the proposed § 46.602 to harmonize 

further OHRP’s final rule with FDA’s. 

These changes include the following: 

• Section 46.502(a) (which was 

§ 46.602(a) in the NPRM) was modified 

to remove the requirement to submit the 

earned degree and the title of the senior 

or head official of the institution or 

organization operating the IRB who is 

responsible for overseeing the activities 

performed by the IRB. This section also 

was modified to require submission of 

the street address (if different from the 

mailing address) for the institution or 

organization operating the IRB. 

• Section 46.502(b) (which was 

§ 46.602(b) in the NPRM) was modified 

to remove the requirement to submit the 

title of the contact person providing the 

registration information. This section 

also was modified to require submission 

of the mailing address of this contact 

person. 

• Section 46.502(c) (which was 

§ 46.602(c) in the NPRM) was modified 

to require submission of the IRB’s phone 

number, facsimile number, mailing 

address, street address (if different from 

the mailing address), and electronic 

mail address. 

• Section 46.502(d) (which was 

§ 46.602(d) in the NPRM) was modified 

to remove the requirement to submit the 

gender, earned degree, title, mailing 

address, and facsimile number of the 

IRB chairperson. 

As stated in the preamble to the 

proposed rule, the Internet registration 

site will request more information from 

IRBs reviewing research conducted or 

supported by HHS than from IRBs 

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, the Internet site would clarify 

that IRBs regulated solely by FDA are 

not required to provide the additional 

information. Likewise, in those 

instances where the registration site 

would seek additional information from 

IRBs regulated by FDA but not regulated 

by HHS, the Internet site would clarify 

that IRBs regulated by HHS are not 

required to provide such information. 

One commenter suggested that the 

rule make clear what of the information 

submitted is available through a 

Freedom of Information Act (FOIA) 

request. OHRP notes that although the 

IRB registration system information is 

subject to FOIA, disclosure 

determinations will be made in 

accordance with applicable exemptions. 

One commenter questioned whether, 

if an IRB was originally registered with 

the U.S. Department of Education (ED) 

and reviews both ED and HHS research 

projects, the proposed registration 

update will meet the ED requirements. 

ED has informed OHRP that ED will rely 

upon the HHS IRB registration system 

and indicated that ED would ensure that 

the IRB will be registered with OHRP. 

One commenter asserted that if HHS 

requires IRBs to register but does not 

require industry and investigators to use 

a registered IRB, then only the IRBs are 

at risk of being penalized for a failure 

to register. The commenter suggested 

that HHS should impose a financial 

penalty on the investigators and 

sponsors who do not use a registered 

IRB. OHRP declines to impose monetary 

penalties on investigators and sponsors 

who do not use a registered IRB for 

review of research. OHRP does not have 

the legal authority to impose fines for 

failure to maintain IRB registration 

information. Furthermore, OHRP notes 

that an IRB cannot be designated under 

an assurance of compliance approved 

for federalwide use by OHRP if it fails 

to register. OHRP believes that the 

registration requirement is both simple 

and straightforward, so it does not 

expect that institutions or organizations 

operating IRBs designated under FWAs 

will refuse or fail to register or revise 

their registration information. 

One commenter asked whether IRBs 

will receive confirmation that the IRB is 

registered. Confirmation of registration 

will be provided to the registering entity 

under the IRB registration system. 

One commenter expressed concern 

that the proposed rule change will 

hinder small- to medium-sized 

organizations which wish to conduct 

HHS-supported research because such 

smaller organizations may lack 

resources to support standing IRBs. 

OHRP finds that this regulatory change 

does not mandate that every research 

organization that receives HHS support 

must have its own IRB. OHRP 

anticipates that an institution without 

an IRB that wishes to conduct HHSsupported human subjects research may 

designate under its FWA an 

independent IRB or another institution’s 

IRB for review of research, and that this 

IRB will be registered in accordance 

with the regulatory requirements. 

Summary of Key Changes in the Final 

Rule 

After considering the comments on 

the proposed rule, OHRP is adopting the 

rule largely as it was proposed. The 

following key changes have been made 

in the final rule: 

1. The designation of proposed 

subpart F has changed to subpart E and 

the numbering of the provisions has 

changed from §§ 46.601–605 to 46.501– 

505. 

2. The proposed requirement to 

collect 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 (which was 

§ 46.602(e) in the NPRM) has been 

deleted from the final rule. However, 

the IRB registration form will continue 

to include IRB roster information as part 

of the IRB registration process since this 

information is required by 45 CFR 

46.103(b)(3). 

3. Section 46.502(a) of the final rule 

(which was § 46.602(a) in the NPRM) 

was modified to remove the requirement 

to submit the earned degree and title of 

the senior or head official of the 

organization or institution operating the 

IRB who is responsible for overseeing 

activities performed by the IRB. This 

section also was modified to require 

submission of the street address (if 

different from the mailing address) for 

the institution or organization operating 

the IRB. 

4. Section 46.502(b) of the final rule 

(which was § 46.602(b) in the NPRM) 

was modified to remove the requirement 

to submit the title of the contact person 

providing the registration information. 

This section also was modified to 

require submission of the mailing 

address of this contact person. 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2403 

5. Section 46.502(c) of the final rule 

(which was § 46.602(c) in the NPRM) 

was modified to require submission of 

the IRB’s phone number, facsimile 

number, mailing address, street address 

(if different from the mailing address), 

and electronic mail address. 

6. Section 46.502(d) of the final rule 

(which was § 46.602(d) in the NPRM) 

was modified to remove the requirement 

to submit the gender, earned degree, 

title, mailing address and facsimile 

number of the IRB chairperson. 

7. Section 46.502(e) of the final rule 

(which was § 46.602(f) in the NPRM) 

was modified to require submission of 

the approximate number of all active 

protocols and active protocols 

conducted or supported by HHS, rather 

than the number ranges (small, medium, 

or large) for total active protocols and 

active protocols supported by HHS, as 

proposed in the NPRM. 

8. The proposed requirement to 

submit information regarding whether 

the institution or IRB organization 

registering an IRB is accredited (which 

was in § 46.602(h) of the NPRM) has 

been deleted from the final rule. 

9. Section 46.503 of the final rule 

(which was § 46.603 in the NPRM) was 

modified to clarify that IRB registration 

becomes effective when reviewed and 

accepted by OHRP, rather than when 

HHS posts registration information on 

its website. 

10. Section 46.504 of the final rule 

(which was § 46.604 in the NPRM) was 

modified to require electronic 

submission of registration information 

unless an institution or organization 

lacks the ability to do so. 

11. Section 46.505 of the final rule 

(which was § 46.605 in the NPRM) was 

modified to remove the requirement that 

information regarding IRB roster 

changes must be submitted within 90 

days because 45 CFR 46.103(b)(3) 

already requires that changes in IRB 

roster information be reported to OHRP. 

Other minor changes have been made 

in the final rule for purposes of clarity 

and accuracy. 

III. What Happens if an IRB Does Not 

Register or Fails To Update its 

Registration Information? 

An IRB cannot be designated under an 

FWA if it fails to register. If an FWA 

submitted to OHRP for approval 

designates an IRB that has not been 

registered, OHRP will not approve the 

FWA with the designation of that IRB. 

If an IRB designated under an FWA 

fails to appropriately update its 

registration information in accordance 

with § 46.505 of the final rule, OHRP 

could restrict or revoke its approval of 

the FWA. For example, if an IRB fails 

to appropriately update its registration 

information in accordance with § 46.505 

of the final rule, OHRP could take 

appropriate action under the 

institution’s FWA and OHRP’s 

compliance oversight policies and 

procedures. OHRP believes that the 

registration requirement in the final rule 

is both simple and straightforward, so it 

does not expect that institutions or 

organizations operating IRBs designated 

under FWAs will refuse or fail to 

register or update their registration 

information. 

IV. Who Has Access to the IRB 

Registration Information Submitted to 

HHS? 

OHRP has posted and will continue to 

post on its Web site the following 

information collected under the IRB 

registration process: 

1. The name, location, and OHRPassigned number (called an IORG 

number) of each institution or 

organization that has registered an IRB. 

The IORG number is a unique number 

assigned by OHRP to an institution or 

organization the first time that it 

registers an IRB. This number is to be 

provided to OHRP whenever an 

institution or organization subsequently 

updates or renews the existing 

registration of any of its IRBs or registers 

a new IRB. Provision of the IORG 

number allows OHRP to efficiently track 

and organize all IRB registration 

information submitted by the same 

institution or organization. 

2. The name, location, registration 

expiration date, and OHRP-assigned 

registration number of each registered 

IRB. The first time an IRB is registered, 

OHRP assigns it a separate unique IRB 

registration number. This number is to 

be provided to OHRP whenever an 

institution or organization subsequently 

updates or renews an IRB registration. 

Provision of the IRB registration number 

allows OHRP to efficiently track and 

organize all IRB registration information 

submitted by an institution or 

organization for the same IRB. 

Furthermore, an institution submitting 

an FWA includes the IRB registration 

number for each IRB designated under 

its FWA, thereby eliminating the need 

for multiple submissions of the same 

registration information to OHRP. 

Although all other information 

collected by the IRB registration is 

subject to FOIA, disclosure 

determinations will be made in 

accordance with applicable exemptions. 

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 OHRP will be 

transferred to a separate server which 

will not be publicly accessible. 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 database, 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. 

V. Implementation 

This rule is effective July 14, 2009. 

This protracted effective date is 

necessary to (a) allow refinement of the 

electronic registration system so that it 

corresponds to this final rule and to 

FDA’s final rule, and (b) obtain OMB 

review and approval for the information 

collection requirements of this rule. 

Initial registration with all required 

information must be submitted within 

60 days of the effective date of the rule, 

by September 14, 2009. For any IRB 

currently registered with OHRP, the 

institution or organization operating the 

IRB must submit all information 

required under this rule by the threeyear expiration date previously assigned 

by OHRP or within 90 days of any 

changes regarding the contact person 

who provided the IRB registration 

information or the IRB chairperson. 

VI. 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 

(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 (42 

U.S.C. 289(b)). These authorities are 

delegated to OHRP (67 FR 10216–18, 

March 6, 2002). 

By requiring IRB registration, the rule 

will aid in the efficient implementation 

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2404 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

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, collection of the 

information required under the rule will 

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 

this rule. 

VII. Economic Impact Analysis 

OHRP has examined the impact of the 

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). OHRP 

believes that this final rule is not a 

significant regulatory action as defined 

by the Executive Order. 

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. 

Because the required registration 

information is minimal and the costs 

associated with registration is low, 

OHRP certifies that the final rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that an agency 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 current 

threshold after adjustment for inflation 

is $127 million, using the most current 

(2006) Implicit Price Deflator for the 

Gross Domestic Product. OHRP does not 

expect this final rule to result in any 

one-year expenditure that would meet 

or exceed this amount. 

The rule requires IRBs designated 

under an assurance of compliance 

approved for Federalwide use by OHRP 

to register with HHS. The information 

sought through the registration process 

is minimal, consisting largely of the 

following: The name, mailing address, 

and street address (if different from the 

mailing address) for the institution or 

organization operating the IRB; the 

names, addresses, phone numbers, 

facsimile numbers, and electronic mail 

addresses of (i) the senior officer or head 

official of the institution or organization 

operating the IRB who is responsible for 

overseeing the activities performed by 

the IRB, and (ii) the contact person 

providing the registration information; 

the name, phone number, and electronic 

mail address of the IRB chairperson; 

and, the approximate numbers of all 

active research protocols, active 

protocols conducted or supported by 

HHS, and full-time equivalent positions 

devoted to the IRB’s administrative 

activities. 

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 will 

spend $40 for an initial registration ($40 

per hour × 1 hour per initial 

registration). 

OHRP estimates that the renewal or 

update of an IRB registration will 

require less time, especially if the IRB 

is only verifying existing information. If 

renewing or updating an IRB 

registration requires 30 minutes, then 

the cost of renewing or updating would 

be approximately $20 ($40 per hour × 

0.5 hour per registration renewal or 

update). 

Additionally, assuming that the 

maximum number of IRBs that will be 

subject to registration annually would 

be 6,000, OHRP estimates that 2,000 

IRBs will complete one new registration 

and one update each year and the other 

4,000 IRBs will complete two updates or 

renewals each year. The total annual 

burden costs for 6,000 IRBs are 

projected to be $280,000 (2,000 new IRB 

registrations × 1 hour × $40/hr = 

$80,000; 1 renewal/update of these 

2,000 IRBs × 0.5 hr × $20/0.5 hr = 

$40,000; 4,000 IRBs will complete 2 

updates/renewals each year, 4,000 IRBs 

× 0.5 hr × $20/0.5 hr × 2 = 160,000). 

Given the minimal registration 

information that would be required and 

the low costs associated with 

registration, this rule is not a significant 

regulatory action, and OHRP certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. The rule 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 one-year 

expenditure of $100 million or more, 

OHRP is not required to perform a costbenefit analysis under the Unfunded 

Mandates Reform Act. 

VIII. 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. 

IX. Paperwork Reduction Act 

This 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). In compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3507(d)), OHRP will obtain OMB 

review and approval for the information 

collection requirements of this rule. 

X. Federalism 

OHRP has analyzed this 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, we 

have 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. 

List of Subjects in 45 CFR Part 46 

Health—Clinical research, Medical 

research, Human research subjects, 

Reporting and recordkeeping 

requirements. 

Dated: December 31, 2008. 

Donald Wright, 

Principal Deputy Assistant Secretary for 

Health. 

Approved: January 6, 2009. 

Michael O. Leavitt, 

Secretary of Health and Human Services. 

■ Accordingly, 45 CFR part 46 is 

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). 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2405 

■ 2. Subpart E is added to part 46 to 

read as follows: 

Subpart E—Registration of 

Institutional Review Boards 

Sec. 

46.501 What IRBs must be registered? 

46.502 What information must be provided 

when registering an IRB? 

46.503 When must an IRB be registered? 

46.504 How must an IRB be registered? 

46.505 When must IRB registration 

information be renewed or updated? 

§ 46.501 What IRBs must be registered? 

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 be registered with 

HHS. An individual authorized to act on 

behalf of the institution or organization 

operating the IRB must submit the 

registration information. 

§ 46.502 What information must be 

provided when registering an IRB? 

The following information must be 

provided to HHS when registering an 

IRB: 

(a) The name, mailing address, and 

street address (if different from the 

mailing address) of the institution or 

organization operating the IRB(s); and 

the name, mailing address, phone 

number, facsimile number, and 

electronic mail address of the senior 

officer or head official of that institution 

or organization who is responsible for 

overseeing activities performed by the 

IRB. 

(b) The name, mailing address, phone 

number, facsimile number, and 

electronic mail address of the contact 

person providing the registration 

information. 

(c) The name, if any, assigned to the 

IRB by the institution or organization, 

and the IRB’s mailing address, street 

address (if different from the mailing 

address), phone number, facsimile 

number, and electronic mail address. 

(d) The name, phone number, and 

electronic mail address of the IRB 

chairperson. 

(e)(1) The approximate numbers of: 

(i) All active protocols; and 

(ii) Active protocols conducted or 

supported by HHS. 

(2) For purpose of this regulation, an 

‘‘active protocol’’ is any protocol for 

which the IRB conducted an initial 

review or a continuing review at a 

convened meeting or under an 

expedited review procedure during the 

preceding twelve months. 

(f) The approximate number of fulltime equivalent positions devoted to the 

IRB’s administrative activities. 

§ 46.503 When must an IRB be registered? 

An IRB must be registered before it 

can be designated under an assurance 

approved for federalwide use by OHRP 

under § 46.103(a). IRB registration 

becomes effective when reviewed and 

accepted by OHRP. The registration will 

be effective for 3 years. 

§ 46.504 How must an IRB be registered? 

Each IRB must be registered 

electronically through http:// 

ohrp.cit.nih.gov/efile unless an 

institution or organization lacks the 

ability to register its IRB(s) 

electronically. If an institution or 

organization lacks the ability to register 

an IRB electronically, it must send its 

IRB registration information in writing 

to OHRP. 

§ 46.505 When must IRB registration 

information be renewed or updated? 

(a) Each IRB must renew its 

registration every 3 years. 

(b) The registration information for an 

IRB must be updated within 90 days 

after changes occur regarding the 

contact person who provided the IRB 

registration information or the IRB 

chairperson. The updated registration 

information must be submitted in 

accordance with § 46.504. 

(c) Any renewal or update that is 

submitted to, and accepted by, OHRP 

begins a new 3-year effective period. 

(d) An institution’s or organization’s 

decision to disband a registered IRB 

which it is operating also must be 

reported to OHRP in writing within 30 

days after permanent cessation of the 

IRB’s review of HHS-conducted or 

-supported research. 

[FR Doc. E9–588 Filed 1–14–09; 8:45 am] 

BILLING CODE 4150–36–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 05–312; FCC 08–256] 

Digital Television Distributed 

Transmission System Technologies 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of six months, 

the information collection(s) associated 

with section 73.626(f) of the rules, and 

that this rule will take effect as of the 

date of this notice. On December 5, 

2008, the Commission published the 

summary document of the Report and 

Order, In the Matter of the Digital 

Television Distributed Transmission 

System Technologies, MB Docket No. 

05–312, FCC 08–256, at 73 FR 74047. 

The Ordering Clause of the Report and 

Order stated that the Commission would 

publish a notice in the Federal Register 

announcing when OMB approval for 

this rule section which contains 

information collection requirements has 

been received and when the revised rule 

will take effect. This notice is consistent 

with the statement in the Report and 

Order. 

DATES: Effective January 15, 2009. 

FOR FURTHER INFORMATION CONTACT: For 

additional information, please contact 

Evan Baranoff, Evan.Baranoff@fcc.gov, 

of the Media Bureau, Policy Division, 

(202) 418–2120. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on December 

29, 2008, OMB approved, for a period of 

six months, the information collection 

requirement(s) contained in Section 

73.626(f) of the rules. The Commission 

publishes this notice to announce the 

effective date of this rule. If you have 

any comments on the burden estimates 

listed below, or how the Commission 

can improve the collections and reduce 

any burdens caused thereby, please 

contact Cathy Williams, Federal 

Communications Commission, Room 1– 

C823, 445 12th Street, SW., Washington, 

DC 20554. Please include OMB Control 

Numbers 3060–0027 and 3060–0029, in 

your correspondence. The Commission 

will also accept your comments via the 

Internet if you send them to 

PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an e-mail to 

fcc504@fcc.gov or call the Consumer & 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the Commission is notifying the public 

that it received OMB approval on 

December 29, 2008, for the information 

collection requirement(s) contained in 

the Commission’s rules at 47 CFR 

73.626(f). 

Under 5 CFR 1320, an agency may not 

conduct or sponsor a collection of 

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