2358 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

party listed in Appendix A to 31 CFR 

Chapter V with the bracketed suffix 

[NPWMD] of an item subject to the EAR. 

If OFAC authorizes an export from the 

United States or an export or reexport 

by a U.S. person to a party listed in 

Appendix A to 31 CFR Chapter V with 

the bracketed suffix [NPWMD], such 

authorization constitutes authorization 

for purposes of the EAR as well. 

(ii) U.S. persons must seek 

authorization from BIS for the export or 

reexport to a party listed in Appendix 

A to 31 CFR Chapter V with the 

bracketed suffix [NPWMD] of any item 

subject to the EAR that is not subject to 

OFAC’s regulatory authority pursuant to 

Executive Order 13382. 

(iii) Non-U.S. persons must seek 

authorization from BIS for any export 

from abroad or reexport to a party listed 

in Appendix A to 31 CFR Chapter V 

with the bracketed suffix [NPWMD] of 

any item subject to the EAR. 

(iv) Any export or reexport to a party 

listed in Appendix A to 31 CFR Chapter 

V with the bracketed suffix [NPWMD] of 

any item subject to the EAR and not 

authorized by OFAC is a violation of the 

EAR. 

(v) Any export or reexport by a U.S. 

person to a party listed in Appendix A 

to 31 CFR Chapter V with the bracketed 

suffix [NPWMD] of any item subject to 

the EAR that is not subject to regulation 

by OFAC and not authorized by BIS is 

a violation of the EAR. Any export from 

abroad or reexport by a non-U.S. person 

to a party listed in Appendix A to 31 

CFR Chapter V with the bracketed suffix 

[NPWMD] of any item subject to the 

EAR and not authorized by BIS is a 

violation of the EAR. 

(3) Relation to other EAR license 

requirements. The license requirements 

in this section supplement any other 

requirements set forth elsewhere in the 

EAR. 

(b) License exceptions. No license 

exceptions are available for the EAR 

license requirements imposed in this 

section. 

(c) Licensing policy. Applications for 

EAR licenses required by this section 

generally will be denied. You should 

consult with OFAC concerning 

transactions subject to OFAC licensing 

requirements. 

(d) Contract sanctity. Contract 

sanctity provisions are not available for 

license applications reviewed under this 

section. 

PART 746—[AMENDED] 

■ 7. The authority citation for part 746 

continues to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec 1503, 

Public Law 108–11, 117 Stat. 559; 22 U.S.C. 

6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 

E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., 

p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 

Comp., p. 899; E.O. 13222, 3 CFR, 2001 

Comp., p. 783; Presidential Determination 

2003–23 of May 7, 2003, 68 FR 26459, May 

16, 2003; Presidential Determination 2007–7 

of December 7, 2006, 72 FR 1899 (January 16, 

2007); Notice of July 23, 2008, 73 FR 43603 

(July 25, 2008). 

■ 8. Revise § 746.7 to read as follows: 

§ 746.7 Iran. 

The Treasury Department’s Office of 

Foreign Assets Control (OFAC) 

administers a comprehensive trade and 

investment embargo against Iran. This 

embargo includes prohibitions on 

exports and certain reexport 

transactions involving Iran, including 

transactions dealing with items subject 

to the EAR. These prohibitions are set 

forth in OFAC’s Iranian Transactions 

Regulations (31 CFR part 560). In 

addition, BIS maintains licensing 

requirements on exports and reexports 

to Iran under the EAR as described in 

paragraph (a)(1) of this section or 

elsewhere in the EAR (See, e.g., 

§ 742.8—Anti-terrorism: Iran). 

(a) License requirements. 

(1) EAR license requirements. A 

license is required under the EAR to 

export or reexport to Iran any item on 

the CCL containing a CB Column 1, CB 

Column 2, CB Column 3, NP Column 1, 

NP Column 2, NS Column 1, NS 

Column 2, MT Column 1, RS Column 1, 

RS Column 2, CC Column 1, CC Column 

2, CC Column 3, AT Column 1 or AT 

Column 2 in the Country Chart Column 

of the License Requirements section of 

an ECCN or classified under ECCNs 

0A980, 0A982, 0A983, 0A985, 0E982, 

1C355, 1C395, 1C980, 1C981, 1C982, 

1C983, 1C984, 2A994, 2D994, 2E994, 

5A980, 5D980, or 5E980. 

(2) BIS authorization. To avoid 

duplication, exporters or reexporters are 

not required to seek separate 

authorization from BIS for an export or 

reexport subject both to the EAR and to 

OFAC’s Iranian Transactions 

Regulations. Therefore, if OFAC 

authorizes an export or reexport, such 

authorization is considered 

authorization for purposes of the EAR as 

well. Transactions that are not subject to 

OFAC regulatory authority may require 

BIS authorization. 

(b) Licensing Policy. Applications for 

licenses for transactions for 

humanitarian reasons or for the safety of 

civil aviation and safe operation of U.Sorigin aircraft will be considered on a 

case-by-case basis. Licenses for other 

purposes generally will be denied. 

(c) License Exceptions. No license 

exceptions may be used for exports or 

reexports to Iran. 

(d) EAR Anti-terrorism controls. The 

Secretary of State has designated Iran as 

a country that has repeatedly provided 

support for acts of international 

terrorism. Anti-terrorism license 

requirements and licensing policy 

regarding Iran are set forth in § 742.8 of 

the EAR. 

(e) Prohibition on exporting or 

reexporting EAR items without required 

OFAC authorization. No person may 

export or reexport any item that is 

subject to the EAR if such transaction is 

prohibited by the Iranian Transactions 

Regulations (31 CFR part 560) and not 

authorized by OFAC. The prohibition of 

this paragraph (e) applies whether or 

not the EAR requires a license for the 

export or reexport. 

Dated: January 9, 2009. 

Christopher R. Wall, 

Assistant Secretary for Export 

Administration. 

[FR Doc. E9–726 Filed 1–14–09; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 56 

[Docket No. FDA–2004–N–0117] (formerly 

Docket No. 2004N–0242) 

RIN 0910–AB88 

Institutional Review Boards; 

Registration Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, we) is issuing a 

final rule to require institutional review 

boards (IRBs) to register through a 

system maintained by the Department of 

Health and Human Services (HHS). The 

registration information includes 

contact information (such as addresses 

and telephone numbers), the number of 

active protocols involving FDAregulated products reviewed during the 

preceding 12 months, and a description 

of the types of FDA-regulated products 

involved in the protocols reviewed. The 

IRB registration requirements will make 

it easier for FDA to inspect IRBs and to 

convey information to IRBs. 

DATES: This rule is effective July 14, 

2009. This effective date is necessary to 

allow refinement of the electronic 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2359 

registration system so that it 

corresponds to this final rule. All IRBs 

must comply with the initial registration 

requirement and, if necessary, make 

required revisions to their registrations 

by September 14, 2009. 

FOR FURTHER INFORMATION CONTACT: Erik 

Mettler, Office of Policy, Planning and 

Preparedness, Food and Drug 

Administration, WO1, rm. 4324, Silver 

Spring, MD 20993–0002, 301–796–4830. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

What Led Us to Issue This Rule? 

IRBs are ‘‘boards, committees, or 

groups formally designated by an 

institution to review, to approve the 

initiation of, and to conduct periodic 

review of, biomedical research 

involving human subjects’’ (see 21 CFR 

56.102(g)). An IRB’s primary purpose 

during such reviews is to assure the 

protection of the rights and welfare of 

human subjects (id.). FDA’s general 

regulations pertaining to IRBs are at part 

56 (21 CFR part 56). (While section 

520(g) of the Federal Food, Drug, and 

Cosmetic Act (‘‘the act’’) (21 U.S.C. 

360j(g)) refers to ‘‘institutional review 

committees’’ rather than IRBs, FDA 

considers institutional review 

committees to be IRBs and to be subject 

to the IRB regulations.) 

Even though IRBs play an important 

role in the conduct of clinical 

investigations regulated by FDA, we 

have never compiled a comprehensive 

list of IRBs involved in reviewing 

clinical investigations regulated by 

FDA. Existing FDA regulations have 

required some, but not all, clinical 

investigators or sponsors of clinical 

investigations to provide IRB names and 

addresses to FDA, and the requirements 

differ slightly among the different types 

of products regulated by FDA. For 

example, for human drug products, the 

sponsor must disclose the name and 

address of ‘‘each reviewing’’ IRB (see 21 

CFR 312.23(a)(6)(iii)(b)). For medical 

devices, the sponsor must disclose the 

names and addresses of IRBs that ‘‘have 

been asked or will be asked’’ to review 

the investigation (see 21 CFR 

812.20(b)(7)) (emphasis added). For 

other types of clinical investigations 

regulated by FDA (such as food additive 

studies involving human subjects), the 

regulations do not expressly require the 

sponsor or the clinical investigator to 

disclose or keep records showing an 

IRB’s name and address, and they make 

no distinction between ‘‘reviewing 

IRBs’’ and IRBs that have been asked or 

will be asked to review a study. 

In 1998, the Department of Health and 

Human Services’ Office of the 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 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’’ (see Office of 

the Inspector General, Department of 

Health and Human Services, 

Institutional Review Boards: a Time for 

Reform, pages 20 and 21, June 1998). 

After reviewing the OIG’s 

recommendation, we concluded that 

IRB registration would serve several 

important goals. IRB registration would: 

• Enable us to identify more precisely 

those IRBs reviewing clinical 

investigations regulated by FDA. At 

present, much of our knowledge about 

the identities and numbers of IRBs 

reviewing clinical investigations 

regulated by FDA is based on 

information from persons conducting or 

sponsoring clinical investigations rather 

than from IRBs themselves. This 

information may be obsolete (because 

there may be no obligation to update the 

information) or incomplete (because the 

requirements to report the names and 

addresses of IRBs are not uniform across 

all FDA-regulated products); 

• Enable us to send educational 

information and other information to 

IRBs. Because we lack an accurate list 

of IRBs, our outreach and educational 

efforts are not as efficient as they might 

be. Changes in IRB addresses result in 

returned mail, and newly formed IRBs 

may not appear in FDA’s mailing lists; 

and 

• Help us identify IRBs for 

inspection, because we would have a 

more accurate list of IRBs. 

Consequently, FDA, in consultation 

with the Department of Health and 

Human Services, Office for Human 

Research Protections (OHRP), published 

a proposed rule in the Federal Register 

of July 6, 2004 (69 FR 40556), that 

would require IRB registration for IRBs 

reviewing clinical investigations 

involving FDA-regulated products. 

OHRP issued a companion proposed 

rule which appeared in the Federal 

Register of July 6, 2004 (69 FR 40584) 

that would require registration for IRBs 

reviewing federally supported research. 

The final OHRP IRB registration rule is 

published elsewhere in this issue of the 

Federal Register. 

The goal of the two rules is to create 

a simple, electronic registration system 

that all IRBs, regardless of whether they 

review clinical investigations regulated 

by FDA or federally supported research, 

can use. 

II. What Comments Did We Receive? 

A. How Many Comments Did We 

Receive, and Who Submitted 

Comments? 

We received over 15 comments in 

response to the proposed rule. 

Individuals, IRB members, IRB 

associations, an IRB accreditation 

association, government, health, 

academic or trade associations, a 

university system, and drug companies 

submitted comments. In general, the 

comments supported IRB registration, 

although some disagreed with specific 

aspects of the proposal or with other 

issues that were discussed in the 

preamble to the proposed rule. To make 

it easier to identify comments and our 

responses, the word ‘‘Comment,’’ in 

parentheses, will appear before the 

comment’s description, and the word 

‘‘Response,’’ in parentheses, will appear 

before our response. We have also 

numbered each comment to help 

distinguish between different 

comments. The number assigned to each 

comment is purely for organizational 

purposes and does not signify the 

comment’s value or importance or the 

order in which it was received. 

B. Who Must Register? (Section 

56.106(a)) 

Proposed § 56.106(a) would require 

the following IRBs to register: 

• Each IRB in the United States that 

reviews clinical investigations regulated 

by FDA under sections 505(i) (21 U.S.C. 

355(i)) or 520(g) of the act; and 

• Each IRB in the United States that 

reviews clinical investigations that are 

intended to support applications for 

research or marketing permits for FDAregulated products. 

The preamble to the proposed rule 

invited comment on whether there are 

circumstances in which foreign IRBs 

should be required or invited to register 

(see 69 FR 40556 at 40558). 

(Comment 1) One comment stated 

that foreign IRBs are not needed in 

America. 

(Response) The comment may have 

misinterpreted the preamble. The issue 

is not whether foreign IRBs should or 

should not review studies, but rather 

whether foreign IRBs should be 

included in the IRB registration system. 

(Comment 2) Several comments 

differed as to whether foreign IRBs 

should have to register. One comment 

would require foreign IRBs to register if 

they review research conducted in the 

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2360 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

United States; the same comment would 

give foreign IRBs the option to register 

if they review research conducted 

outside the United States that may be 

used to support a future marketing 

application in the United States. 

Several comments would allow for 

voluntary registration of foreign IRBs or 

ethical review committees. Two 

comments explained that registering 

foreign IRBs would enable them to have 

access to educational materials and 

other information. However, one 

comment would limit such registration 

to foreign IRBs reviewing research 

conducted in the United States, and 

another comment noted that local 

privacy laws in foreign countries might 

affect a foreign IRB’s ability to provide 

certain registration information. 

In contrast, one comment said that we 

should respect oversight of ethical 

review committees by foreign 

authorities and that we should not 

impose ‘‘additional bureaucracy.’’ 

Similarly, another comment opposed 

registering foreign IRBs, stating that 

such registration could pose ‘‘significant 

difficulties’’ for clinical investigators 

and sponsors and that foreign laws and 

regulations might make it difficult for 

foreign IRBs to register. 

(Response) We agree in part with the 

comments. We agree that foreign IRBs 

would benefit from educational and 

other materials that would be sent to 

registered IRBs. Therefore, we have 

revised § 56.106(a) to allow for 

voluntary registration by foreign IRBs 

and by any domestic IRB that is not 

otherwise required to register. 

We decline to require registration by 

foreign IRBs that review research to be 

conducted in the United States. We do 

not believe a significant number of 

foreign IRBs review research that is to 

be conducted in the United States. 

Furthermore, requiring registration by 

foreign IRBs that review research 

conducted in the United States could 

lead to arguments over the validity of 

our regulatory authority when applied 

to actions occurring in a foreign 

country. 

As for possible problems foreign IRBs 

might encounter in registering 

information due to foreign laws and 

regulations, the comments did not 

identify specific registration elements 

that would be a problem. Consequently, 

we lack sufficient information to 

determine whether we should modify 

certain IRB registration elements to 

accommodate foreign IRBs. 

(Comment 3) One comment asked us 

to clarify whether the reference to 

section 520(g) of the act was limited to 

research done under an investigational 

device exemption (IDE) or encompassed 

all investigational devices in a clinical 

investigation. 

(Response) The reference to section 

520(g) of the act encompasses all 

investigational devices in a clinical 

investigation, regardless of whether 

FDA approval of an IDE is needed in 

accordance with 21 CFR part 812 for the 

clinical investigation. 

(Comment 4) One comment asked us 

to clarify whether the rule applied to 

‘‘non-local’’ or ‘‘commercial’’ IRBs. 

(Response) The comment did not 

explain what it meant by the terms 

‘‘non-local’’ or ‘‘commercial’’ IRB. For 

purposes of this response, we will 

assume that a ‘‘non-local’’ IRB is one 

that is physically located away from the 

clinical trial site(s) and that a 

‘‘commercial’’ IRB is one that is paid to 

review research. 

If the ‘‘non-local’’ or ‘‘commercial’’ 

IRB is located in the United States and: 

• Reviews clinical investigations 

regulated by FDA under sections 505(i) 

or 520(g) of the act; or 

• Reviews clinical investigations that 

are intended to support applications for 

research or marketing permits for FDAregulated products, then the non-local 

or commercial IRB must register under 

§ 56.106(a). If the non-local or 

commercial IRB does not perform any of 

the reviews described immediately 

above or is outside the United States, 

then it may register voluntarily. 

C. What Information Must an IRB 

Register? (Section 56.106(b)) 

Proposed § 56.106(b) would describe 

the information that IRBs would provide 

as part of the registration process. For 

example, proposed § 56.106(b)(1) would 

require the name and mailing address of 

the institution operating the IRB and the 

name, mailing address, phone number, 

facsimile number, and electronic mail 

address of the senior officer of that 

institution who is responsible for 

overseeing the IRB’s activities. (A 

facsimile number also is known more 

commonly as a ‘‘fax number.’’) 

(Comment 5) Several comments 

addressed the registration information 

in proposed § 56.106(b) generally. Two 

comments said that the registration 

information that OHRP and FDA would 

require should either be the same or that 

information required by OHRP, but not 

by FDA, should be clearly delineated 

and marked as optional for IRBs that are 

subject to FDA regulation. Similarly, 

one comment said that questions 

relating to research funded by HHS, 

which were part of OHRP’s proposed 

registration system, should be identified 

clearly so IRBs that do not review HHSfunded research are not obliged to 

answer those questions. 

Another comment said the proposed 

registration information is appropriate. 

One comment urged us to reexamine 

the registration information to assure 

that the information is necessary to 

support the rule’s stated goals. 

(Response) We coordinated our rule 

with OHRP and tailored our respective 

registration information elements to be 

as consistent as possible and to use the 

same internet-based registration system. 

We agree that the IRB registration 

system should specify whether certain 

registration information is optional or 

not required for IRBs subject only to our 

jurisdiction. The preamble to the 

proposed rule stated that, ‘‘In those 

instances where the Internet registration 

site would seek more information than 

FDA would require under this proposal, 

the site would clarify that IRBs 

regulated solely by FDA may, but are 

not required to, provide the additional 

information’’ (69 FR 40556 at 40558). 

The Internet registration site will be 

structured so that required information 

will be identified or marked as such, 

and IRBs indicating that they are 

registering pursuant to FDA’s regulation 

also will be directed to questions 

requesting information required only 

under FDA’s regulation. 

(Comment 6) Proposed § 56.106(b)(1) 

would require IRBs to provide the name 

and mailing address of the institution 

operating the IRB and the name, mailing 

address, phone number, facsimile 

number, and electronic mail address of 

the ‘‘senior officer of that institution 

who is responsible for overseeing 

activities performed by the IRB.’’ The 

preamble to the proposed rule explained 

that the senior officer ‘‘must not be an 

IRB member, IRB staff, or a sponsor or 

investigator participating in an 

investigation under review by that IRB’’ 

(see 69 FR 40556 at 40558). 

Several comments addressed this 

provision. Two comments supported the 

proposed requirement, but two other 

comments stated that our interpretation 

of ‘‘senior officer’’ was too prohibitive 

or too restrictive. These comments said 

that if a senior officer is on the IRB, his 

or her membership should not 

invalidate registration or subject the IRB 

to enforcement action. 

Another comment questioned what 

we meant when we referred to ‘‘IRB 

staff.’’ The comment said that some IRBs 

distinguish staff from IRB members to 

ensure the IRB’s integrity and 

independence. The comment suggested 

that we list persons who cannot be a 

‘‘senior officer’’ and that we delete ‘‘IRB 

staff’’ from that list. 

(Response) We agree, in part, with the 

comments. We recognize that, in some 

cases, it may not be feasible to identify 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2361 

a ‘‘senior officer’’ who is not also an IRB 

member or IRB staff. However, our 

experience indicates that IRBs 

sometimes form subcommittees or other 

groups and that the institutions 

overseeing the IRBs may not be aware of 

these subcommittees or other groups. 

Thus, when we said that the ‘‘senior 

officer’’ should not be an IRB member 

or IRB staffer, our goal was to ensure 

that the institution overseeing the IRB’s 

activities is truly aware of those 

activities. For these reasons, where 

feasible, we recommend that the senior 

officer not be an IRB member or an IRB 

staffer. 

Additionally, as the preamble to the 

proposed rule stated, information 

regarding the institution will enable us 

to identify the institution and to 

determine whether problems that might 

exist for one IRB at that institution exist 

at other IRBs affiliated with that 

institution (see 69 FR 40556 at 40558). 

Additionally, on our own initiative, 

we have revised § 56.106(b)(1) to require 

the street address for the institution if 

the street address is different from the 

institution’s mailing address. 

(Comment 7) One comment said we 

should ensure that any addresses and 

telephone numbers are current and are 

kept current. The comment suggested 

that we issue fines and penalties if IRBs 

fail to keep such information current. 

(Response) Section 56.106(e) requires 

IRBs to revise their registration 

information within 90 days if a contact 

person or chairperson information 

changes; this would encompass changes 

in the contact person’s or chairperson’s 

telephone number. 

As for the comment’s suggestion of 

imposing fines and penalties, we do not 

have legal authority to impose fines for 

failure to maintain IRB registration 

information. As for other penalties, we 

discuss the consequences of failing to 

register in comment 24 of this 

document. 

(Comment 8) Proposed § 56.106(b)(2) 

would require IRBs to provide the IRB’s 

name, the names of each IRB chair 

person and each contact person (if one 

exists) for the IRB, and the IRB’s mailing 

address, street address (if different from 

the mailing address), phone number, 

facsimile number, and electronic mail 

address. 

One comment supported the proposal. 

However, another comment noted that 

the OHRP proposal would require IRBs 

to provide the name, gender, degree, 

scientific or nonscientific specialty, and 

affiliation of each IRB member and 

suggested that we revise our rule to 

require the same information as the 

OHRP rule. 

(Response) We agree, in part, and 

disagree, in part, with the comment’s 

suggestion that we require the same 

information as OHRP’s rule. We decline 

to revise the rule as requested by the 

comment. Unlike OHRP, we have never 

required IRBs to give us the names, 

educational background, and 

qualifications of all IRB members. Our 

rule does not include this information 

because our regulatory emphasis has 

been on the IRB’s overall composition. 

Consequently, our final rule does not 

require such information about 

individual IRB members. 

We have, however, revised 

§ 56.106(b)(2) to replace ‘‘chair person’’ 

with ‘‘chairperson.’’ This change reflects 

the common spelling for this noun and 

does not alter the application or 

interpretation of § 56.106(b)(2). 

Additionally, we have revised 

§ 56.106(b)(2) to require the phone 

number and electronic mail address for 

the IRB chairperson; this will enable us 

to communicate with the IRB 

chairperson quickly if such a need 

arises. 

On our own initiative, we have 

revised § 56.106(b)(2) to delete the 

parenthetical of ‘‘(if one exists)’’ after 

‘‘the contact person’s name’’ and to 

require and the name, mailing address, 

phone number, facsimile number, and 

electronic mail address of the contact 

person providing the registration 

information. This information will 

enable us to communicate with the 

contact person if any questions arise 

regarding the IRB or its registration 

information, and the information now 

required is similar to that required for 

the contact person under OHRP’s rule. 

We also have reorganized the provision 

to make it easier to understand what 

information is required. 

(Comment 9) Proposed § 56.106(b)(3) 

would require IRBs to provide the 

‘‘number of active protocols (small, 

medium, or large) involving FDAregulated products reviewed.’’ The 

proposal explained that a ‘‘small’’ 

number of protocols is 1 to 25 protocols; 

‘‘medium’’ is 26 to 499 protocols, and 

‘‘large’’ is 500 protocols or more. 

Several comments interpreted this 

provision in different ways or sought 

clarification as to its meaning. In brief: 

• One comment asked us to define 

‘‘protocol’’ because it said questions 

would arise regarding multi-site studies 

involving a single protocol. 

• Another comment would redefine 

the numerical ranges so that ‘‘small’’ 

would be 1 to 99 protocols, ‘‘medium’’ 

would be 100 to 499 protocols, ‘‘large’’ 

would be 500 to 1,999 protocols, and 

‘‘very large,’’ a new category, would be 

2,000 protocols or more. The comment 

explained that a ‘‘substantial number’’ 

of organizations oversee thousands of 

protocols and that these organizations 

operate differently compared to those 

that review 500 protocols. 

• Another comment expressed 

concern about the protocol numbers, 

stating that it was unclear how useful or 

accurate the data would be due to 

complexities in IRB review and 

‘‘protocol driven research activities,’’ 

the level of IRB review (such as full IRB 

review or expedited review), and 

frequent or daily changes in protocol 

review numbers. 

Similarly, another comment stated 

that protocols are neither uniform nor 

uniformly complex, so that protocol 

activity is not a reasonable basis for 

determining IRB activity. A third 

comment said that we should consider 

the protocol ranges to be only 

approximations of IRB workloads and 

use the information carefully and 

cautiously in evaluating or 

characterizing IRBs. 

• Another comment disputed the 

need for protocol review information, 

arguing that compliance with regulatory 

requirements is an issue regardless of 

the number of protocols reviewed by an 

IRB. 

(Response) The preamble to the 

proposed rule explained that 

information regarding the number of 

protocols reviewed would enable us to 

determine how active an IRB is and to 

assign our inspection resources based 

on IRB activity levels (see 69 FR 40556 

at 40558). Our intent was not to get an 

exact or precise figure, and the 

proposal’s use of ‘‘small,’’ ‘‘medium,’’ 

and ‘‘large’’ protocol ranges reflected 

that intent. 

Consequently, we decline to revise 

the rule to define ‘‘protocol’’ in the final 

rule. Webster’s II—New Riverside 

University Dictionary defines 

‘‘protocol,’’ in relevant part, as ‘‘the plan 

for a scientific experiment or treatment’’ 

(see Webster’s II—New Riverside 

University Dictionary at page 947 

(1988)). Thus, in the comment’s 

scenario, if an IRB conducts one review 

for a multi-site study, that single review 

could be considered as one ‘‘protocol.’’ 

If an IRB conducts separate reviews for 

individual study sites, then it 

conceivably could have reviewed 

multiple ‘‘protocols’’ notwithstanding 

the fact that the study plan remains 

essentially the same for all sites. 

However, on our own initiative, we 

have amended § 56.106(b)(3) to define 

what the term ‘‘active protocol’’ means. 

The final rule defines ‘‘active protocol’’ 

as ‘‘any protocol for which an IRB 

conducted an initial review or a 

continuing review at a convened 

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2362 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

meeting or under an expedited review 

procedure during the preceding 12 

months.’’ We have made this change to 

be consistent with changes made by 

OHRP in its final rule. 

With respect to the proposal’s 

numerical ranges and their usefulness to 

us, we reiterate that our intent was to 

get a general—rather than a precise— 

sense of how active IRBs are and to 

assign our limited inspectional 

resources more efficiently and 

effectively. We recognize that there are 

different types of IRB review and that 

changes in an IRB’s workload could 

make an IRB’s protocol estimate 

outdated or obsolete at a later point in 

time. However, given the protocol 

ranges were created simply to give us an 

idea about an IRB’s activity, we have 

revised the rule to eliminate the 

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

Instead, the final rule requires an 

approximate number of active protocols 

reviewed, but we neither expect nor 

want IRBs to constantly change or 

update their protocol numbers 

whenever their protocol numbers 

fluctuate. If the approximate number of 

protocols changes after initial IRB 

registration, the IRB should report the 

new protocol number as part of the reregistration process which takes place 

every 3 years. 

As for compliance activities, we 

believe the comment may have 

misinterpreted the preamble to the 

proposed rule. We did not state that we 

would base inspections solely on an 

IRB’s self-reported level of ‘‘small,’’ 

‘‘medium,’’ or ‘‘large’’ numbers of 

protocols reviewed. We simply said that 

the information would help us assign 

inspection resources based on IRB 

activity levels. 

To put it another way, we have 

limited inspectional resources, and our 

field staffs that inspect IRBs are also 

responsible for many other types of 

inspections and activities. We must 

prioritize our routine IRB inspections in 

some manner to make the most efficient 

use of our resources. Such prioritization 

of IRB inspections is not tantamount to 

declaring, as the comment suggests, that 

IRBs reviewing ‘‘small’’ or ‘‘medium’’ 

numbers of protocols do not have to 

comply with FDA regulations or that we 

enforce our requirements differently 

depending on whether an IRB reviews a 

‘‘small,’’ ‘‘medium,’’ or ‘‘large’’ number 

of protocols. Nevertheless, given that 

the final rule does not contain the 

‘‘small,’’ ‘‘medium,’’ or ‘‘large’’ protocol 

ranges, the issue is largely moot. 

(Comment 10) Proposed § 56.106(b)(4) 

would require IRBs to describe the types 

of FDA-regulated products, such as 

biological products, color additives, 

food additives, human drugs, or medical 

devices, involved in the protocols that 

they review. 

Two comments addressed this 

provision. One comment stated that it 

had no objection to the requirement 

provided that the description could be 

simple or generic without numerical 

ranges associated with each product 

type. Another comment said the 

descriptions would be appropriate only 

if we used the information for purposes 

of sending useful and targeted 

information to IRBs. The comment also 

said that the description should be 

generic and without numerical ranges 

associated with product types. 

(Response) We agree with the 

comments. Section 56.106(b)(4) merely 

seeks a generic description of the FDAregulated products in the protocols 

reviewed by the IRB. So, for example, if 

the IRB reviews protocols for human 

drug studies, the description, to satisfy 

§ 56.106(b)(4), could simply be ‘‘human 

drugs.’’ If the IRB reviews protocols for 

human drug and medical device studies, 

the description would be ‘‘human 

drugs’’ and ‘‘medical devices.’’ We also 

note that the electronic registration 

system will list the types of FDAregulated products and allow 

individuals to check the appropriate 

boxes relating to those products and to 

check ‘‘other’’ and explain what the 

‘‘other’’ FDA-regulated products are. 

Furthermore, § 56.106(b)(4) does not 

require IRBs to assign numerical values 

to the FDA-regulated product types. As 

the comments noted, our intent is to use 

this information to send productspecific information to IRBs, and we can 

do so with a simple description of 

product types. 

(Comment 11) Proposed § 56.106(b)(5) 

would require an indication whether the 

IRB is accredited and, if so, the date of 

the last accreditation and the name of 

the accrediting body or organization. 

The preamble to the proposed rule 

stated that we recognized that IRB 

accreditation is a developing concept 

and invited comment on ‘‘the perceived 

value of collecting information on the 

accreditation status of IRBs’’ (see 69 FR 

40556 at 40558). 

We received more than 10 comments 

on IRB accreditation issues, and the 

comments reflected a considerable 

difference of opinion regarding IRB 

accreditation and whether we should 

require information about such 

accreditation. In brief, the comments 

stated: 

• IRB accreditation information may 

give FDA useful information in deciding 

which IRBs to inspect and may help us 

decide whether to focus educational 

activities on certain areas. One comment 

added that accreditation information 

would help us evaluate the value of IRB 

accreditation. In contrast, one comment 

said that IRB accreditation information 

will not give FDA new information that 

will be useful in assessing 

accreditation’s value; 

• FDA should refer to accreditation of 

human research protection programs 

rather than accreditation of IRBs; 

• FDA should require information 

about the name of the accrediting 

organization under which the IRB 

functions or collect information about 

accreditation type or level. One 

comment explained that one body has 

two different accreditation categories; 

• The additional reporting burden 

should not be passed on to the 

institution; 

• FDA should delete the provision 

because accreditation information can 

be collected without the need for a 

regulation or is publicly available from 

accrediting organizations. One comment 

added that accreditation information, if 

it were part of the IRB registration 

requirement, might be unreliable 

because our rule would require reregistration every 3 years; and 

• Accreditation does not accurately 

represent a measure of compliance with 

human subject protection requirements. 

Similarly, an IRB’s lack of accreditation 

could be misconstrued as reflecting on 

the quality of the IRB’s human subject 

protection program. In contrast, one 

comment strongly encouraged IRBs to 

become accredited, and another 

comment said that accreditation implies 

that a certain standard has been 

achieved. 

(Response) The final rule omits 

accreditation information from the IRB 

registration requirements. We agree that, 

if necessary, we can obtain accreditation 

information from the accreditation 

organizations themselves and that the 

resulting information may be more 

reliable or accurate, given that the rule 

does not require certain registration 

information to be updated until reregistration. We also agree that, as a 

general matter, accreditation does not 

ensure or demonstrate that a particular 

action was done correctly; instead, 

accreditation may increase one’s 

confidence that the accredited body is 

capable of performing a particular 

action correctly. 

Furthermore, we continue to believe 

that accreditation, insofar as human 

subject protection is concerned, is still 

a developing concept. Consequently, we 

will continue to follow such 

accreditation activities, but will not 

require accreditation information as part 

of IRB registration. 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2363 

Finally, because the final rule does 

not require accreditation information, 

the comment regarding reporting 

burdens is moot. 

D. When Must an IRB Register? (Section 

56.106(c)) 

Proposed § 56.106(c) would have IRBs 

register once and to renew their 

registrations every 3 years. Initial IRB 

registration would occur within 30 days 

before the date when the IRB intends to 

review clinical investigations regulated 

by FDA. IRB registration would become 

effective upon HHS posting of the 

registration information on its Web site. 

(Comment 12) One comment would 

have us consider IRBs to be registered 

as soon as they complete submitting the 

registration information regardless of 

whether the IRB submitted the 

information electronically or in writing. 

Another comment suggested that the 

electronic registration system 

acknowledge or document that the IRB 

has registered. Another comment stated 

that, if IRB registration is to identify 

IRBs for future inspections, there is no 

need for a 30-day ‘‘waiting’’ period. 

A different comment said that the 30- 

day time period might interfere with 

IRB review, particularly expedited 

reviews and full IRB reviews that take 

less than 30 days. The comment 

suggested that we revise the rule so that 

IRBs may not issue a determination on 

FDA-regulated research until they have 

registered. 

Another comment asked us to clarify 

when IRBs must register. The comment 

explained that the codified provision 

directed IRBs to submit an initial 

registration within 30 days before the 

date when the IRB intends to review 

clinical investigations regulated by 

FDA. The comment said that the word 

‘‘within’’ could mean that an IRB could 

register ‘‘anytime between one and 30 

days before reviewing a protocol,’’ but 

that the preamble to the proposed rule 

interpreted proposed § 56.106(c) as 

requiring registration at least 30 days 

before reviewing the protocol. The 

comment preferred giving IRBs the 

ability to register any time between 1 

and 30 days before reviewing protocols 

in FDA-regulated research. 

(Response) We agree, in part, with the 

comments. For IRBs that register 

electronically, the registration system 

will notify them that they are registered. 

This notification will be sent to the 

electronic mail address that the IRB 

provides as part of the registration 

process. The IRB’s registration will be 

effective after review and acceptance by 

HHS. We have amended § 56.106(c) 

regarding the time at which IRB 

registration becomes effective to 

correspond to changes made by OHRP 

in its final rule which is published 

elsewhere in this issue of the Federal 

Register. OHRP revised a comparable 

provision in its rule to clarify when IRB 

registration would become effective. 

For IRBs that submit their registration 

information in writing, our experience 

with written forms in other contexts 

suggests that some individuals will not 

complete the forms or omit required 

information. As a result, we may need 

to contact individuals to obtain the 

missing information. Therefore, it 

would be more practical for us to 

consider IRBs who submit their 

registration information in writing to be 

registered only after they have 

submitted all required registration 

information, we have entered that 

information into the electronic 

registration system, and the information 

is reviewed and accepted by HHS. 

As for the comments concerning the 

30-day timeframe and the suggestion 

that we amend the rule so that IRBs 

cannot issue decisions on FDAregulated research until they have 

registered, we have decided to eliminate 

the 30-day timeframe from the final 

rule. We note that IRB registration, 

alone, does not address issues regarding 

an IRB’s competence or expertise, nor 

does it require IRBs to meet a particular 

standard in order to conduct a review. 

However, because it is important to FDA 

to assemble an accurate IRB database, 

we have revised § 56.106(c) to state that: 

‘‘Each IRB must submit an initial 

registration. The initial registration must 

occur before the IRB begins to review a 

clinical investigation described in 

paragraph (a) of this section. Each IRB 

must renew its registration every 3 

years. IRB registration becomes effective 

after review and acceptance by HHS.’’ 

(Comment 13) One comment would 

require IRBs to renew their registration 

every year instead of every 3 years. The 

comment said that 3 years would be too 

long a time period. 

(Response) We decline to revise the 

rule as suggested by the comment. IRB 

registration does not confer any 

particular status on IRBs, nor does 

registration, alone, reflect upon an IRB’s 

competence or capabilities. Moreover, 

given that the information we seek 

through IRB registration is quite basic 

(as in names and addresses) and that 

§ 56.106(e) describes how and when 

IRBs are to revise their registration 

information, annual registration would 

not appear to confer any advantages or 

make registration information more 

accurate or reliable. Consequently, we 

decline to require IRBs to register 

annually. 

E. Where Can an IRB Register? (Section 

56.106(e)) 

Proposed § 56.106(e) would direct 

IRBs to register at a specific Internet 

address or, if an IRB lacked the ability 

to register electronically, to send its 

registration information to a specific 

mail address. We indicated that we 

would provide the Internet address and 

mail address in the final rule. We also 

invited comment on whether we should 

discontinue written IRB registration 

procedures after some time period has 

elapsed, because we did not know how 

widespread Internet access is among 

IRBs (see 69 FR 40556 at 40558). 

(Comment 14) Several comments 

pertained to the registration site(s). One 

comment said we should maintain one 

common registration site with OHRP 

and that the registration system should 

automatically include currently 

registered IRBs. The comment said the 

registration system should also allow 

such IRBs to retain their assigned 

numbers. The comment acknowledged 

the intent to create a single registration 

site, but implied that the proposed 

rule’s omission of a specific Internet 

address created concern. Another 

comment supported creation of a 

simple, electronic registration system. 

(Response) We agree that a single 

Internet registration site should be used 

for electronic registrations and have 

always worked with OHRP towards that 

end. We were unable to provide a 

specific Internet address at the time of 

the proposed rule because the electronic 

registration system was still under 

development. The final rule now states 

that the Internet registration address is 

http://ohrp.cit.nih.gov/efile. 

Additionally, as we stated in the 

preamble to the proposed rule, OHRP 

will continue to recognize previous IRB 

registrations (see 69 FR 40556 at 40558). 

(Comment 15) One comment asked 

whether entities that have more than 

one IRB at the same location need to 

register more than once or whether they 

could register once and provide 

multiple pieces of information in 

connection with a single registration. 

(Response) The electronic registration 

system will assign an organization 

number to each entity, and this will 

enable the entity to register several IRBs 

without having to enter the same data 

repeatedly for each IRB. 

(Comment 16) Two comments 

encouraged us to have the electronic 

registration system consider IRBs to be 

registered automatically once an IRB 

completes the electronic registration 

process or to send acknowledgements to 

the IRBs once they complete the 

electronic registration process. 

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(Response) As we stated in our 

response to comment 12 of this 

document, when an IRB completes the 

electronic registration process and HHS 

has reviewed and accepted the 

information, the electronic registration 

system will notify IRBs that they are 

registered. 

(Comment 17) Several comments 

responded to our question whether we 

should discontinue written IRB 

registrations after some time period has 

elapsed. One comment supported 

conversion to electronic registration as 

soon as possible, but said it is important 

to allow small organizations the time to 

acquire the necessary technology. The 

comment agreed that not all institutions 

have electronic capabilities or Internet 

access. 

Another comment supported giving 

IRBs the option to submit registration 

information in writing for a 

predetermined period of time, but did 

not suggest any time period. A different 

comment also supported the written 

registration option, but suggested that it 

be available only for 2 years. 

Another comment opposed 

discontinuing written IRB registration. 

The comment said that there are adverse 

consequences to both the IRB and any 

sponsor or investigator that might use 

an unregistered IRB (which appeared to 

be a reference to a later discussion, in 

the preamble to the proposed rule, about 

‘‘What Happens if an IRB Does Not 

Register?’’ (see 69 FR 40556 at 40559)), 

so we should continue to make written 

IRB registration possible. 

(Response) While we continue to 

believe that most IRBs will use the 

electronic registration system, we do not 

know how many IRBs will use the 

written registration option, and the 

administrative record for this 

rulemaking does not give us sufficient 

basis to set a deadline at which we 

would end the written registration 

option. (We realize that one comment 

suggested a 2-year period, but, given 

that IRBs have 3 years to renew 

registrations, discontinuing written 

registrations after 2 years would not give 

IRBs the opportunity to renew their 

registrations in writing.) Consequently, 

until we become more experienced with 

IRB registrations, we will continue to 

offer written registration as an 

alternative to electronic registration, and 

the final rule states that IRBs that lack 

the ability to register electronically must 

send their registration information, in 

writing, to the Good Clinical Practice 

Program (HF–34), Office of Science and 

Health Coordination, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. 

F. How Does an IRB Revise Its 

Registration Information? (Section 

56.106(e)) 

Proposed § 56.106(e) would have IRBs 

revise their registration information 

within specific timeframes if certain 

changes occurred. For example, if the 

IRB’s contact or chair person 

information changes, proposed 

§ 56.106(e) would require the IRB to 

change its registration information 

within 90 days of the change. If the IRB 

decided to disband or to discontinue 

reviewing FDA-regulated clinical 

investigations, it would report that 

change within 30 days. All other 

information changes would be reported 

when the IRB renews its registration. 

(Comment 18) Two comments pointed 

out a discrepancy between the proposed 

rule and its preamble. The comments 

noted that the preamble to the proposed 

rule said that if an IRB reviews new 

types of FDA-regulated products, it 

would revise its registration information 

within 30 days (see 69 FR 40556 at 

40559), yet proposed § 56.106(e) was 

silent regarding such changes. The 

comments suggested that we reconcile 

the codified text with the preamble. 

(Response) The comments were 

correct. We inadvertently omitted 

changes in the IRB’s review of FDAregulated research from proposed 

§ 56.106(e), and we have revised the 

rule so that IRBs must revise their 

registration information within 30 days 

if they review new types of FDAregulated products. Additionally, on our 

own initiative, we have added a 

parenthetical phrase to clarify that a 

decision to review ‘‘new types of FDAregulated products’’ should be 

interpreted as a decision to review a 

different category of FDA-regulated 

products, such as a decision to review 

studies pertaining to food additives 

when the IRB previously reviewed 

studies pertaining to drug products. We 

do not want IRBs to revise their 

registration information if they decide to 

review studies pertaining to 

subcategories within the same class of 

FDA-regulated products; for example, if 

an IRB previously reviewed studies 

pertaining to drugs intended to treat 

cardiac conditions and then decided to 

review studies pertaining to drugs 

intended to treat cancer, both types of 

studies would still pertain to drug 

products, so there would be no ‘‘new 

type’’ of FDA-regulated product within 

§ 56.106(e). 

(Comment 19) One comment 

addressed IRBs that have decided to 

disband. The comment said that the 

process of closing an IRB may take 

longer than 30 days, so requiring IRBs 

to revise their registration information 

within 30 days of a decision to disband 

would put an ‘‘undue burden’’ on IRBs 

and the institutions responsible for the 

IRBs. 

(Response) We agree in part, and 

disagree in part with the comment. We 

agree that, in some cases, closing an IRB 

may take more than 30 days, but, in 

other cases, the process may take less 

time. In other words, IRBs vary in size, 

resources, organization, and complexity, 

and, as a result, different IRBs will take 

different amounts of time to perform the 

same or similar functions. 

The comment also may have 

misinterpreted the proposed rule. 

Proposed § 56.106(e) stated that an IRB’s 

decision to disband or to discontinue 

reviewing FDA-regulated clinical 

investigations is a change that must be 

reported within 30 days of that change; 

thus, the proposal would begin the time 

period when IRB decides to close, not 

when the IRB finally closes. 

Nevertheless, for consistency with 

OHRP’s final rule (which appears 

elsewhere in this issue of the Federal 

Register), we have revised § 56.106(e) to 

state that an IRB’s decision to disband 

is a change that must be reported 

‘‘within 30 days of permanent cessation 

of the IRB’s review of research.’’ In the 

preamble to the OHRP final rule, OHRP 

states that ‘‘the date of permanent 

cessation of the IRB’s review of * * * 

research would occur on or after the 

IRB’s decision to disband, but not before 

the IRB’s decision to disband was 

made.’’ 

Furthermore, given the simplicity of 

the electronic registration system, we do 

not believe that IRBs or their 

institutions will find it ‘‘unduly’’ 

burdensome to report the IRB’s decision 

to disband. 

(Comment 20) One comment would 

shorten the time period for reporting 

changes in the IRB’s contact or chair 

person information from 90 days to 60 

days. 

(Response) We decline to revise the 

rule as suggested by the comment. The 

comment did not identify any advantage 

in shortening the timeframe, and we do 

not believe that reducing the timeframe 

by 30 days will confer any significant 

benefit. 

G. What Other Comments Did We 

Receive? 

1. What Information Will Be Publicly 

Available? 

The preamble to the proposed rule 

referred to the OHRP proposal for 

information regarding public disclosure 

of IRB registration information, the 

Freedom of Information Act (FOIA), and 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2365 

the Privacy Act of 1974 (see 69 FR 

40556 at 40557). It also stated that, 

insofar as FDA’s registration system was 

concerned, the name of the institution 

operating the IRB and the IRB’s name 

will be publicly accessible, and all other 

IRB registration information would be 

subject to public disclosure under FOIA 

and our public information regulations 

at part 20 (21 CFR part 20) (see id.). 

(Comment 21) One comment said 

that, in addition to the institution’s 

name and the IRB’s name, we should 

make the following information publicly 

available: 

• The name, address, and telephone 

number of the IRB contact; and 

• For accredited IRBs, information 

relating to that accreditation. 

Another comment asked us to clarify 

what information would be publicly 

available under FOIA. 

(Response) All registration 

information required under this rule 

will be subject to FOIA and any other 

applicable statutes and regulations 

pertaining to public disclosure. Please 

note that certain information may be 

withheld from public disclosure or may 

require an individual’s consent to 

public disclosure (see, e.g., § 20.63(e) 

(stating that a request for all records 

relating to a specific individual will be 

denied as a clearly unwarranted 

invasion of personal privacy unless 

accompanied by the written consent of 

the individual named)). 

As for accreditation information, 

accreditation status is not required 

under the final rule, so that information 

will not be publicly available from us or 

from OHRP. 

(Comment 22) One comment 

suggested that sponsors and 

investigators have access to the IRB 

registration database. The comment said 

that sponsors and investigators 

currently have access to Federal-wide 

assurances data and suggested that, if 

sponsors and investigators could not 

have access to the IRB registration 

database, we or OHRP should issue a 

report of IRB registrations or issue 

certificates to individual IRBs. 

(Response) OHRP currently posts all 

registered IRBs on its Web site, 

including the name and location of the 

organization operating the IRB(s) and 

the name and location of each IRB. 

We decline to issue reports on IRB 

registration or certificates to show that 

an IRB is registered. As we stated in our 

response to comment 12 of this 

document, IRB registration, alone, does 

not address issues regarding an IRB’s 

competence or expertise, nor does it 

require IRBs to meet a particular 

standard in order to conduct a review. 

(Comment 23) One comment said we 

should establish a link to the publicly 

available IRB registration information 

from the portion of our own Web site 

that pertains to ‘‘Good Clinical Practices 

in FDA-Regulated Clinical Trials,’’ 

located at http://www.fda.gov/oc/gcp/ 

default.htm. 

(Response) We agree with the 

comment and have modified our Web 

site accordingly. 

2. What Happens if an IRB Does Not 

Register? 

The preamble to the proposed rule 

stated that sponsors and investigators 

who used unregistered IRBs might be 

using IRBs that ‘‘would not have had the 

benefit of receiving educational 

materials from FDA and would not have 

been identified on an FDA IRB 

registration list for future inspection’’ 

(see 69 FR 40556 at 40559). Thus, the 

preamble to the proposed rule added 

that, ‘‘to the extent that any existing 

FDA regulation requires a sponsor or 

investigator to comply with [part 56] or 

to use an IRB that complies with part 

56, FDA will consider sponsors and 

investigators using an unregistered IRB 

to be in conflict with their regulatory 

obligations’’ (id.). 

The preamble to the proposed rule 

also noted how we considered other 

options to require sponsors and 

investigators to use only registered IRBs, 

such as refusing to consider information 

from an application for a research 

permit for a clinical investigation that is 

reviewed or is to be reviewed by an 

unregistered IRB (id.). The preamble to 

the proposed rule also invited comment 

on what sanctions or administrative 

mechanisms, if any, should or might be 

used against sponsors and investigators 

who use unregistered IRBs and whether 

any additional changes to our 

regulations were necessary. 

(Comment 24) We received many 

comments relating to sanctions, other 

regulatory changes, and ensuring that 

sponsors and investigators use only 

registered IRBs. The comments reflected 

a considerable difference of opinion. For 

example: 

• One comment said we should 

impose and enforce ‘‘high fines’’ for 

failure to follow human subject 

protection regulations; 

• Several comments said that the 

forms investigators currently use (Form 

FDA 1572) could be used to reinforce or 

otherwise highlight the need to use only 

registered IRBs, but the comments 

differed as to whether investigators 

should be subject to any sanctions if 

they use an unregistered IRB. For 

example, one comment said failure to 

use a registered IRB should be treated 

the same as any other breach of an 

investigator’s responsibilities, but others 

said that IRBs, rather than sponsors or 

investigators, should be responsible for 

any failure to register. One comment 

also opposed placing an investigation 

on clinical hold because, the comment 

argued, clinical holds are appropriate 

when the rights and/or safety of human 

subjects are in jeopardy or other 

material, noncompliance concerns are 

evident; the comment said that failure to 

register does not mean improper 

oversight by the IRB or by the sponsor. 

Some comments argued that sponsors 

and investigators should not be obliged 

to monitor an IRB’s registration status. 

In contrast, one comment would have us 

amend the investigational new drug 

(IND) application regulations to 

authorize us to place a study on clinical 

hold if the sponsor or investigator uses 

an unregistered IRB. The same comment 

suggested that we consider additional 

enforcement options, such as ‘‘refusing 

to consider information from an 

application for a research permit for a 

clinical investigation that is reviewed or 

is to be reviewed by an unregistered 

IRB.’’ 

• Several comments, mostly from 

pharmaceutical firms or trade 

associations, opposed any changes 

outside the IRB regulations. The 

comments, in general, felt that the 

existing IND regulations were sufficient 

and clear regarding a sponsor’s or 

investigator’s obligation to use IRBs that 

comply with part 56. Some comments 

said we should not expend resources on 

revising the IND regulations but should 

promote awareness of the IRB 

registration requirements instead. 

Another comment, from an association 

of medical colleges, also opposed 

revisions to the IND regulations, stating 

that clinical holds would be unworkable 

because, if an unregistered IRB had 

reviewed a clinical study and the 

clinical study had proceeded, 

retroactive review of the study would be 

impermissible. The comment said we 

should refuse to consider information 

from an application for a research 

permit that is reviewed or is to be 

reviewed by an unregistered IRB. 

• One comment suggested a 

‘‘flexible’’ approach whereby we would 

start by sending a certified letter to an 

unregistered IRB regarding its failure to 

register and include registration 

instructions. If the IRB remained 

unregistered, the comment suggested 

that we inspect the IRB. The comment 

said that this approach would allow us 

to take appropriate action against 

unregistered IRBs without 

‘‘unnecessarily penalizing’’ sponsors 

and investigators who have attempted to 

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2366 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

follow our regulations in good faith. 

Similarly, another comment advocated 

sending letters to IRBs or notices to 

sponsors rather than imposing 

sanctions. 

• One comment agreed with us that 

an IRB’s failure to register would not 

justify disqualification of the IRB under 

§ 56.121 absent the extreme 

circumstances described in 

§ 56.121(b)(1) (the IRB has refused or 

repeatedly failed to comply with 

regulatory requirements) or 

§ 56.121(b)(2) (the noncompliance 

adversely affects the rights or welfare of 

the human subjects in a clinical 

investigation). 

(Response) We agree in part and 

disagree in part with the comments. We 

agree that the existing IND regulations, 

as well as the IDE regulations, are 

sufficient and clear regarding a 

sponsor’s or investigator’s obligation to 

use IRBs that comply with part 56. We 

also agree that an IRB’s failure to 

register, alone, should not lead to 

disqualification proceedings under 

§ 56.121 absent extreme circumstances. 

We intend to educate IRBs, sponsors, 

and investigators about the IRB 

registration requirements and to 

encourage sponsors and investigators to 

use registered IRBs for the same reasons 

we stated in the preamble to the 

proposed rule. 

Given the existing IND and IDE 

regulations and our intent to pursue 

educational efforts, we disagree with 

those comments that would have us 

impose fines or place clinical 

investigations on clinical hold if the 

sponsor or investigator used an 

unregistered IRB. We believe that it 

would be premature for us to consider 

the use of such sanctions before we and 

the regulated community have gained 

sufficient experience with the IRB 

registration program. 

3. What Other Issues Did the Comments 

Raise? 

Several comments addressed issues 

that were either not part of the 

rulemaking or not material to the 

proposed codified text. 

(Comment 25) One comment 

disagreed with the preamble to the 

proposed rule when we stated that our 

knowledge about the identities and 

numbers of IRBs reviewing FDAregulated clinical research is obsolete or 

incomplete (see 69 FR 40556 at 40557). 

The comment said that we require 

sponsors to identify IRBs and that, for 

20 years, OHRP has maintained a list of 

IRBs that have filed assurances (under 

45 CFR part 46). The comment said that 

such past practices were apparently 

sufficient for purposes of conducting 

inspections. 

(Response) We disagree with the 

comment. As we stated in the preamble 

to the proposed rule, existing FDA 

regulations have required some, but not 

all, clinical investigators and sponsors 

to provide IRB names and addresses to 

us, and those regulatory requirements 

differ slightly (see 69 FR 40556 at 

40557). Consequently, because of 

differences within our own regulations, 

we do not have a comprehensive list of 

IRBs that review FDA-regulated 

research. Additionally, because our preexisting regulations do not require 

sponsors and investigators to revise or 

update IRB information if and when the 

IRB changes its address, contact person, 

or chair person, or even, in some cases, 

to provide addresses, contact 

information, or chair person information 

to us, the IRB information we do have 

is not as detailed as the information we 

seek under this rule. 

As for institutions that have filed 

assurances with OHRP under 45 CFR 

part 46, the IRBs associated with such 

institutions are not necessarily identical 

to those that review FDA-regulated 

research. OHRP’s regulations apply to 

institutions that are engaged in human 

subjects research conducted or 

supported by HHS. In contrast, our IRB 

regulations apply to clinical 

investigations regulated by us, 

regardless of whether those 

investigations are conducted or 

supported by HHS. Thus, the fact that 

OHRP has operated an assurance system 

for decades does not necessarily mean 

that the OHRP list of institutions that 

have filed assurances can serve as a list 

of IRBs that review FDA-regulated 

research. 

(Comment 26) One comment said that 

registration and re-registration fees 

should be set at $5,000 to cover costs. 

The comment said that taxpayers should 

not have to pay the fees or fund the 

costs of ‘‘profiteers,’’ and that 

pharmaceutical companies should not 

‘‘get away’’ with low fees when ‘‘they 

can pay their executives $150,000,000 at 

retirement.’’ 

(Response) We decline to revise the 

rule as suggested by the comment. We 

have no express authority to impose 

registration or re-registration fees on 

IRBs. Additionally, the rule is directed 

at IRBs themselves rather than 

pharmaceutical firms, so issues relating 

to pharmaceutical executives’ salaries 

are not relevant to this rulemaking. 

(Comment 27) One comment asked us 

to confirm that our IRB inspections will 

adhere to the guidelines described in 

the ‘‘Guidance for Institutional Review 

Boards and Clinical Investigators.’’ 

(Response) This rulemaking does not 

affect how we conduct IRB inspections. 

We may, however, use IRB registration 

information to help us prioritize 

inspections. Additionally, our receipt of 

more accurate IRB addresses and 

contact information due to IRB 

registration should make it easier and 

more efficient to schedule IRB 

inspections. 

H. What Other Amendment Did We 

Propose? 

The proposal would also make a nonsubstantive amendment to part 56. The 

proposal would revise the definition of 

‘‘An Application for an Investigational 

Device Exemption,’’ at § 56.102(b)(12), 

to eliminate its reference to 21 CFR part 

813. The preamble to the proposed rule 

explained that this change is necessary 

because we removed the regulations at 

part 813 (which had pertained to 

intraocular lenses) in 1997 (see 62 FR 

4164, January 29, 1997). 

We received no comments on this 

aspect of the proposal. Consequently, 

the final rule deletes a reference to part 

813. 

III. Implementation 

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 to 

OHRP’s final rule. 

IV. Legal Authority 

In general, the act authorizes us to 

issue regulations pertaining to 

investigational uses of FDA-regulated 

products (see, e.g., sections 409(j) (21 

U.S.C. 348(j)) (investigations involving 

food additives); 505(i) (investigations 

involving human drugs); 520(g) 

(investigations involving devices); and 

721(f) (21 U.S.C. 379e(f)) of the act 

(investigations involving color 

additives)). 

The act also requires the submission 

of a petition or application to FDA (see, 

e.g., sections 409(b) (food additive 

petitions); 505(b) (new drug 

applications); 505(j) (abbreviated new 

drug applications); 513(f) (premarket 

notification for devices); 515(c) 

(premarket approval applications for 

devices); 520(m) (humanitarian device 

exemption applications); and 721(b) of 

the act (color additive petitions)) before 

marketing begins. 

To implement these provisions of the 

act, section 701(a) of the act gives us the 

authority to issue regulations for the 

efficient enforcement of the act. By 

requiring IRB registration, the final rule 

will aid in the efficient enforcement of 

the act’s provisions regarding the 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2367 

1Source: United States Department of Labor, 

Bureau of Labor Statistics; National Compensation 

Survey, June 2005. Overall hourly rate in the United 

States for administrators and officials, public 

administration, is $31.54. To account for benefits, 

the hourly rate was increased by 40 percent and 

rounded to the nearest whole dollar. Data accessed 

on August 31, 2006, at http://data.bls.gov. 

investigational use of various FDAregulated products (because then we 

would be able to conduct IRB 

inspections more efficiently) as well as 

those provisions regarding marketing 

applications (because marketing 

applications usually depend on clinical 

investigations involving human 

subjects, and IRBs are supposed to 

provide protections for the rights and 

welfare of such human subjects). 

Moreover, by requiring IRBs to register, 

the final rule will enable FDA to contact 

IRBs more quickly and efficiently on 

various issues, such as adverse reactions 

that may be attributed to a particular 

product, new regulatory requirements or 

policies, or problems associated with a 

particular protocol or clinical 

investigator. Consequently, we conclude 

that we have sufficient legal authority to 

issue the final rule. 

V. Economic Impact Analysis 

We have examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 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). The 

agency believes that this final rule is not 

a significant regulatory action as defined 

by the Executive Order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the required 

registration information is minimal and 

the costs associated with registration are 

low, the agency 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 agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $127 

million, using the most current (2006) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

The final rule requires most IRBs to 

register with FDA. The information 

sought through the registration process 

is minimal, consisting largely of names 

and addresses for a contact person, the 

institution operating the IRB (if an 

institution exists), the head of the 

institution, the IRB, and the IRB 

chairperson. The registration would also 

indicate the approximate number of 

active protocols reviewed and the types 

of FDA-regulated products involved. We 

estimate that initial IRB registration may 

require 1 hour. The average loaded wage 

rate for administrators at public 

institutions is about $44 per hour.1 This 

means that each IRB would spend $44 

for an initial registration ($44 per hour 

x 1 hour per initial registration). 

We estimate that re-registration would 

require less time, especially if the IRB 

verifies existing information. If reregistration requires 30 minutes, then 

the cost of re-registration to each IRB 

would be approximately $22 ($44 per 

hour x 0.5 hours per re-registration). 

Revising an IRB’s registration 

information would probably involve 

costs similar to re-registration costs. If 

the revision requires 30 minutes, then 

the cost of revising an IRB’s registration 

information would be approximately 

$22 per IRB. 

Given the minimal registration 

information that would be required and 

the low costs associated with 

registration, this final rule is not a 

significant regulatory action, and we 

certify that the final rule does not have 

a significant economic impact on a 

substantial number of small entities. 

Therefore, the rule is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866 and does not require a 

Regulatory Flexibility Act analysis. 

Additionally, assuming that an 

estimated 5,000 IRBs would register, the 

final rule will result in a 1-year 

expenditure of $220,000 (5,000 IRBs x 

$44 registration wage costs per IRB). 

Because the total expenditure under the 

rule will not result in a 1-year 

expenditure of $100 million or more, we 

are not required to perform a costbenefit analysis under the Unfunded 

Mandates Reform Act. 

VI. Environmental Impact 

We have determined under 21 CFR 

25.30(h) 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. 

VII. Paperwork Reduction Act of 1990 

This rule contains information 

collection requirements that are subject 

to review by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3520). The title, description, and 

respondent description of the 

information collection provisions are 

shown below with an estimate of the 

annual reporting and recordkeeping 

burden. Included in the estimate is the 

time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. 

Title: Institutional Review Boards: 

Registration Requirements. 

Description: The final rule requires 

IRBs to register with FDA. 

Description of Respondents: 

Businesses and individuals. 

The estimated burden associated with 

the information collection requirements 

of this rule is 8,750 hours. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

56.106(c) (initial registration) 5,000 1 5,000 1 5,000 

56.106(c) (re-registration) 2,500 1 2,500 0.5 1,250 

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2368 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

56.106(e) 5,000 1 5,000 0.5 2,500 

Total 8,750 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our 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 (see Department of Health and 

Human Services, Office of the Inspector 

General, Institutional Review Boards: A 

Time for Reform, page 3, June 8, 1998). 

While not all IRBs are involved in 

clinical investigations regulated by 

FDA, for purposes of the PRA, we will 

use 5,000 as the maximum number of 

IRBs subject to the final rule. 

Additionally, because the final rule 

requires basic information about an IRB 

(such as names and addresses) and 

because registration would, in most 

cases, be done electronically, we will 

assume that registration will take only 1 

hour per IRB. Thus, the total burden 

hours would be 5,000 hours (5,000 IRBs 

x 1 hour per IRB). 

Re-registration and revisions to 

existing registration information should 

require less time than initial 

registration. We will assume that reregistration and revisions will take only 

30 minutes per IRB. We will also 

assume, based on OHRP’s experience 

with its IRB registration program, that 

50 percent of IRBs (2,500) will reregister and that all (5,000) will revise 

their registration information. Therefore, 

the total burden hours for re-registration 

will be 1,250 hours (2,500 IRBs x 0.5 

hours per IRB), and the total burden 

hours for revisions will be 2,500 hours 

(5,000 IRBs x 0.5 hours per IRB). 

Prior to the effective date of this final 

rule, FDA will publish a notice in the 

Federal Register announcing OMB’s 

decision to approve, modify, or 

disapprove the information collection 

provisions in this final rule. In 

compliance with the PRA (44 U.S.C. 

3507(d)), we have submitted the 

information collection requirements of 

this rule to OMB for review. An agency 

may not conduct or sponsor, and a 

person is not required to respond to, a 

collection of information unless it 

displays a currently valid OMB control 

number. 

VIII. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. We have 

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 isnot 

required. 

List of Subjects in 21 CFR Part 56 

Human research subjects, Reporting 

and recordkeeping requirements, Safety. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the 

Commissioner, part 56 is amended as 

follows: 

PART 56—INSTITUTIONAL REVIEW 

BOARDS 

■ 1. The authority citation for 21 CFR 

part 10 continues to read as follows: 

Authority: 21 U.S.C. 321, 343, 346, 346a, 

348, 350a, 350b, 351, 352, 353, 355, 360, 

360c–360f, 360h–360j, 371, 379e, 381; 42 

U.S.C. 216, 241, 262, 263b–263n. 

§ 56.102 [Amended] 

■ 2. Amend § 56.102 in paragraph 

(b)(12) by removing the phrase ‘‘parts 

812 and 813’’ and by adding in its place 

the phrase ‘‘part 812’’. 

■ 3. Add § 56.106 to subpart A to read 

as follows: 

§ 56.106 Registration. 

(a) Who must register? Each IRB in the 

United States that reviews clinical 

investigations regulated by FDA under 

sections 505(i) or 520(g) of the act and 

each IRB in the United States that 

reviews clinical investigations that are 

intended to support applications for 

research or marketing permits for FDAregulated products must register at a site 

maintained by the Department of Health 

and Human Services (HHS). (A research 

permit under section 505(i) of the act is 

usually known as an investigational 

new drug application (IND), while a 

research permit under section 520(g) of 

the act is usually known as an 

investigational device exemption (IDE).) 

An individual authorized to act on the 

IRB’s behalf must submit the 

registration information. All other IRBs 

may register voluntarily. 

(b) What information must an IRB 

register? Each IRB must provide the 

following information: 

(1) The name, mailing address, and 

street address (if different from the 

mailing address) of the institution 

operating the IRB and the name, mailing 

address, phone number, facsimile 

number, and electronic mail address of 

the senior officer of that institution who 

is responsible for overseeing activities 

performed by the IRB; 

(2) The IRB’s name, mailing address, 

street address (if different from the 

mailing address), phone number, 

facsimile number, and electronic mail 

address; each IRB chairperson’s name, 

phone number, and electronic mail 

address; and the name, mailing address, 

phone number, facsimile number, and 

electronic mail address of the contact 

person providing the registration 

information. 

(3) The approximate number of active 

protocols involving FDA-regulated 

products reviewed. For purposes of this 

rule, an ‘‘active protocol’’ is any 

protocol 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 12 months; and 

(4) A description of the types of FDAregulated products (such as biological 

products, color additives, food 

additives, human drugs, or medical 

devices) involved in the protocols that 

the IRB reviews. 

(c) When must an IRB register? Each 

IRB must submit an initial registration. 

The initial registration must occur 

before the IRB begins to review a 

clinical investigation described in 

paragraph (a) of this section. Each IRB 

must renew its registration every 3 

years. IRB registration becomes effective 

after review and acceptance by HHS. 

(d) Where can an IRB register? Each 

IRB may register electronically through 

http://ohrp.cit.nih.gov/efile. If an IRB 

lacks the ability to register 

electronically, it must send its 

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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 2369 

registration information, in writing, to 

the Good Clinical Practice Program (HF– 

34), Office of Science and Health 

Coordination, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. 

(e) How does an IRB revise its 

registration information? If an IRB’s 

contact or chair person information 

changes, the IRB must revise its 

registration information by submitting 

any changes in that information within 

90 days of the change. An IRB’s decision 

to review new types of FDA-regulated 

products (such as a decision to review 

studies pertaining to food additives 

whereas the IRB previously reviewed 

studies pertaining to drug products), or 

to discontinue reviewing clinical 

investigations regulated by FDA is a 

change that must be reported within 30 

days of the change. An IRB’s decision to 

disband is a change that must be 

reported within 30 days of permanent 

cessation of the IRB’s review of 

research. All other information changes 

may be reported when the IRB renews 

its registration. The revised information 

must be sent to FDA either 

electronically or in writing in 

accordance with paragraph (d) of this 

section. 

Dated: January 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–682 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Part 42 

[Public Notice: 6457] 

RIN 1400–AB84 

Visas: Documentation of Immigrants 

Under the Immigration and Nationality 

Act, as Amended: Electronic Petition 

for Diversity Immigrant Status 

AGENCY: State Department. 

ACTION: Final rule. 

SUMMARY: This rule makes final an 

interim rule published in the Federal 

Register on August 18, 2003, amending 

the Department’s regulations pertaining 

to the manner in which aliens may 

petition for the opportunity to 

participate in the Diversity Visa 

Program. The rule changed the standard 

mail-in system previously used to an 

entirely electronic system for the 

purpose of making the process less 

prone to fraud, improve efficiency and 

significantly reduce the processing costs 

to the Government. 

DATES: Effective Date: This rule is 

effective on January 15, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Prosnik, Legislation and 

Regulations Division, Visa Services, 

Department of State, Washington, DC 

20520–0106, (202) 663–1202, e-mail 

(prosnikla@state.gov). 

SUPPLEMENTARY INFORMATION: 

Why is the Department promulgating 

this rule? 

The Department published an interim 

rule, Public Notice 4446 at 68 FR 49353, 

Aug. 18, 2003, with a request for 

comments. The comment period expired 

on October 17, 2003. No public 

comments were received during the 

comment period. 

What did the rule do? 

The rule amended the Department’s 

regulations at 22 CFR 42.33 to establish 

an entirely electronic system utilizing a 

specifically designated Internet Web 

site, by which aliens can petition for the 

opportunity to participate in the 

Diversity Visa Program. 

Why was the petitioning process 

changed? 

There are three main benefits to 

changing the mail-in process to an 

electronic format. First, it helps 

eliminate multiple applications, 

prohibited under INA Section 

204(a)(1)(I). Secondly, it greatly reduces 

the cost of administering the system. 

Finally, it benefits the petitioners by 

immediately notifying them of the 

receipt of the petition, impossible under 

the mail-in system. 

PART 42—VISAS: DOCUMENTATION 

OF IMMIGRANTS UNDER THE 

IMMIGRATION AND NATIONALITY 

ACT, AS AMENDED 

■ Accordingly, the interim rule 

amending 22 CFR part 42 which was 

published at 68 FR 49353 on August 18, 

2003, is adopted as final without 

change. 

Dated: January 2, 2009. 

Janice L. Jacobs, 

Assistant Secretary for Consular Affairs, 

Department of State. 

[FR Doc. E9–698 Filed 1–14–09; 8:45 am] 

BILLING CODE 4710–06–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 203 and 3500 

[Docket No. FR–5180–F–04] 

RIN 2502–AI61 

Real Estate Settlement Procedures Act 

(RESPA): Rule To Simplify and 

Improve the Process of Obtaining 

Mortgages and Reduce Consumer 

Settlement Costs; Deferred 

Applicability Date for the Revised 

Definition of ‘‘Required Use’’ 

AGENCY: Office of the Assistant 

Secretary for Housing-Federal Housing 

Commissioner, HUD. 

ACTION: Final rule. 

SUMMARY: This final rule delays the 

effective date of the definition of 

‘‘required use’’ as revised by HUD’s 

November 17, 2008, final rule amending 

its RESPA regulations. The November 

17, 2008, final rule provides that the 

revised definition is applicable 

commencing January 16, 2009, the 

effective date of the final rule. As a 

result of recently initiated litigation, 

HUD has determined to delay the 

effective date of the revised definition of 

‘‘Required use’’ until April 16, 2009. 

DATES: This correction is effective 

January 16, 2009, The definition of 

‘‘Required use’’ in § 3500.2, as revised 

by HUD’s final rule published on 

November 17, 2008, at 73 FR 68204, is 

delayed until April 16, 2009. 

FOR FURTHER INFORMATION CONTACT: Ivy 

Jackson, Director, or Barton Shapiro, 

Deputy Director, Office of RESPA and 

Interstate Land Sales, Office of Housing, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Room 9158, Washington, DC 20410– 

8000; telephone 202–708–0502 (this is 

not a toll-free telephone number). 

Persons with hearing or speech 

impairments may access this number 

through TTY by calling the toll-free 

Federal Information Relay Service at 

800–877–8339. 

SUPPLEMENTARY INFORMATION: On 

November 17, 2008 (73 FR 68204), HUD 

published a final rule amending its 

regulations to further the purposes of 

the Real Estate Settlement Procedures 

Act (12 U.S.C. 2601–2617) by requiring 

more timely and effective disclosures 

related to mortgage settlement costs for 

federally related mortgage loans to 

consumers. The final rule followed 

publication of a March 14, 2008, 

proposed rule (73 FR 14030) and made 

changes in response to public comment 

and in further consideration of certain 

issues by HUD. Additional information 

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