36986 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Rules and Regulations 

light their METs would incur additional 

costs and time delays and this affects 

their ability to compete with others in 

the market. As stated previously, the 

FAA is not amending the regulations to 

require notice for structures less than 

200 feet AGL in non-airport 

environments. The FAA is providing 

this information to enhance the 

visibility of structures that otherwise 

may be difficult to see due to the terrain 

and the nature of specific operations 

conducted around these METs. While 

this guidance is not mandatory, the FAA 

anticipates that in the interest of 

aviation safety, developers and 

landowners will consider this guidance 

for METs erected in the environments 

described in this document. 

III. Policy 

The FAA recommends voluntary 

marking of METs less than 200 feet AGL 

in accordance with marking guidance 

contained in this document and 

Advisory Circular 70–7460–l, 

Obstruction Marking and Lighting. The 

FAA notes that historically this 

guidance has not been applied to the 

voluntary marking of METs less than 

200 feet AGL. However, the FAA 

recognizes the need to address safety 

impacts to low-level flight operations 

due to the construction of METs in 

remote and rural areas, especially as 

agricultural spraying season approaches. 

Due to the growing concerns expressed 

by operators, associations representing 

agricultural operators, and state and 

local governments throughout the 

agricultural industry, the FAA believes 

that voluntary marking of METs less 

than 200 AGL in remote and rural areas 

enhance the visibility of these structures 

to low level agricultural operations in 

the vicinity of these towers. 

The FAA recommends that 

landowners and developers use 

guidance contained in Advisory 

Circular 70/7460–1, Obstruction 

marking and Lighting for the voluntary 

marking of METs less than 200 feet 

AGL. METs should be painted in 

accordance to criteria contained in 

Chapter 3, paragraphs 30–33 of AC No. 

70/7460–1, specifically, with alternate 

bands of aviation orange and white 

paint. In addition, paragraph 34 states 

that all markings should be replaced 

when faded or otherwise deteriorated. 

The FAA recommends that high 

visibility sleeves be installed on the 

outer guy wires of METs as described in 

this document. The FAA intends, at a 

future date, to amend the advisory 

circular to include guidance on sleeves. 

Additionally, the FAA recommends 

high visibility spherical marker (or 

cable) balls of aviation orange color are 

attached to the guy wires. Spherical 

markers should be installed and 

displayed in accordance to guidance 

contained in this document and 

additional standards contained in 

Chapter 3, paragraph 34 of AC No. 70/ 

70460–1. The FAA, however, recognizes 

various weather conditions and 

manufacturing placement standards 

may affect the placement and use of 

high visibility sleeves and/or spherical 

markers. Thus, flexibility is needed 

when determining sleeve length and 

marker placement on METs. 

Issued in Washington, DC, on June 20, 

2011. 

Dennis E. Roberts, 

Director, ATO Airspace Services, AJV–1. 

[FR Doc. 2011–15746 Filed 6–23–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Parts 734, 740, 743 and 774 

[Docket No. 110210131–1317–01] 

RIN 0694–AF15 

Export Controls for High Performance 

Computers: Wassenaar Arrangement 

Agreement Implementation for ECCN 

4A003 and Revisions to License 

Exception APP 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

Export Administration Regulations 

(EAR) to implement changes made to 

the Wassenaar Arrangement’s List of 

Dual Use Goods and Technologies 

(Wassenaar List) maintained and agreed 

to by governments participating in the 

Wassenaar Arrangement on Export 

Controls for Conventional Arms and 

Dual Use Goods and Technologies 

(Wassenaar Arrangement, or WA) at the 

December 2009 WA Plenary Meeting 

(the Plenary) that relate to Export 

Control Classification Number (ECCN) 

4A003. These changes agreed to at the 

Plenary pertain to raising the Adjusted 

Peak Performance (APP) for digital 

computers in ECCN 4A003. In 

accordance with the National Defense 

Authorization Act (NDAA) for FY 1998, 

the President’s report for High 

Performance Computers was sent to 

Congress on February 7, 2011, to 

identify and set forth a justification for 

the new APP. This rule also makes 

corresponding revisions to License 

Exception APP, the de minimis rule, 

and post shipment verification reporting 

requirements in the EAR. 

Additionally, this rule moves Albania 

and Croatia from Computer Tier 3 to 

Computer Tier 1 in the section of the 

EAR dedicated to export control 

requirements for high performance 

computers. The Administration believes 

Albania and Croatia are eligible to be 

treated as Computer Tier 1 countries 

because their governments have made 

the necessary reforms to allow the 

countries to join the North Atlantic 

Treaty Organization, and have adopted 

accepted global standards in export 

controls. 

DATES: Effective Dates: This rule is 

effective on June 24, 2011. 

FOR FURTHER INFORMATION CONTACT: For 

general questions contact Sharron Cook, 

Office of Exporter Services, Bureau of 

Industry and Security, U.S. Department 

of Commerce at 202–482 2440 or by 

e-mail: sharron.cook@bis.doc.gov. 

For technical questions contact: 

Joseph Young at 202–482–4197 or by 

e-mail at joseph.young@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

In July 1996, the United States and 

thirty-three other countries gave final 

approval to the establishment of a new 

multilateral export control arrangement 

called the Wassenaar Arrangement on 

Export Controls for Conventional Arms 

and Dual Use Goods and Technologies 

(Wassenaar Arrangement or WA). The 

Wassenaar Arrangement contributes to 

regional and international security and 

stability by promoting transparency and 

greater responsibility in transfers of 

conventional arms and dual use goods 

and technologies, thus preventing 

destabilizing accumulations of such 

items. Participating states committed to 

exchange information on exports of dual 

use goods and technologies to nonparticipating states for the purposes of 

enhancing transparency and assisting in 

developing a common understanding of 

the risks associated with the transfers of 

these items. For more information on 

the Wassenaar Arrangement go to 

http://www.wassenaar.org/. 

Many computers are exported and 

reexported using License Exception 

Adjusted Peak Performance (APP). The 

primary eligibility criteria considered 

for this license exception are destination 

country and the processing speed. In the 

past, the processing speed was 

measured using a formula that would 

result in the Composite Theoretical 

Performance (CTP) of a computer. 

Presently, the speed of computers is 

calculated using a formula that results 

in the Adjusted Peak Performance 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Rules and Regulations 36987 

(APP). The countries eligible for export 

or reexport under License Exception 

APP are divided into two groups or 

‘‘Tiers’’, (Tier 1 and Tier 3). Countries 

listed in Tier 1 are ally countries or 

countries that do not pose a national 

security, nuclear or missile threat to the 

United States. Tier 3 Countries are all 

other countries with the exception of 

the terrorist supporting countries listed 

in Country Group E:1 of Supplement 

No. 1 to part 740. 

The National Defense Authorization 

Act (NDAA) Congressional Notification 

Requirement, Subsections 1211(d) and 

(e) of the National Defense 

Authorization Act (NDAA) for FY 1998 

(Pub. L. 105–85, November 18, 1997, 

111 Stat. 1932), provides that a new 

composite theoretical performance level 

for purposes of licensing exports of 

digital computers to Tier 3 countries 

may not take effect until sixty days after 

the President submits a report to 

Congress setting forth the new level and 

the justification for the new level. The 

President sent a report to Congress on 

February 7, 2011 that identifies and 

provides justification for a new 1.5 

Weighted TeraFLOPS (WT) control level 

using the Adjusted Peak Performance 

(APP) formula. 

Revisions to the Commerce Control List 

This rule revises Export Control 

Classification Number (ECCN) 4A003 on 

the Commerce Control List (CCL) to 

implement the changes to the 

Wassenaar List of Dual Use Goods and 

Technologies agreed to at the December 

2009 WA Plenary meeting. These 

changes are described in more detail 

below. 

ECCN 4A003 is amended by: 

—Revising the APP from 0.75 to 1.5 WT 

in the AT control paragraph of the 

License Requirements section to make 

it consistent with the revision in 

4A003.b. 

—Revising the APP from 0.75 to 1.5 WT 

(in two places) in Note 1 of the 

License Requirements section, to 

make it consistent with a revision in 

4A003.b. 

—Revising the APP from 0.75 to 1.5 WT 

in 4A003.b to maintain control of 

leading edge computers, while 

decontrolling older computers. 

Section 740.7 Computers (APP) 

The WA members agreed at the 2009 

Plenary to raise the ‘‘License Exception 

Adjusted Peak Performance’’ (APP) 

parameter in ECCNs 4D001 (0.25 WT), 

and 4E001 (0.25 WT), because of the 

advancement of computer technology. 

In License Exception APP, with regard 

to deemed exports of ‘‘development’’ 

and ‘‘production’’ technology controlled 

by ECCN 4E001 and source code 

controlled by ECCN 4D001, BIS is 

raising the eligibility parameter (APP) 

from 0.5 WT to 1.5 WT for foreign 

nationals of Computer Tier 1 countries 

(with the exception of the countries 

listed in Section 740.7(c)(3)(i) that have 

unlimited APP for ‘‘development’’ and 

‘‘production’’ technology and source 

code) and from 0.1 WT to 0.5 WT for 

foreign nationals of Computer Tier 3 

countries, because of the advancement 

of high performance computer 

technology. 

Albania and Croatia 

This rule removes Albania and 

Croatia from Computer Tier 3 and 

places these countries in Computer Tier 

1 in Section 740.7 License Exception 

APP. The requirements in the 1998 

National Defense Authorization Act 

(NDAA) provides that the removal of a 

country from Tier 3 may take effect 120 

days after Congress receives a report 

justifying such a removal. The President 

sent a report to Congress on February 7, 

2011, therefore the 120 days have 

passed. Albania and Croatia have made 

significant progress in conforming to 

international nonproliferation norms 

and export control standards. Croatia is 

a member of the Australia Group, the 

Nuclear Suppliers Group, and the 

Wassenaar Arrangement. Albania has 

declared its adherence to the 

international export control regimes and 

is working on becoming a member of the 

regimes. Albania and Croatia are parties 

to the Nuclear Non-Proliferation Treaty, 

the Chemical Weapons Convention, and 

the Biological Weapons Convention. In 

addition, Albania and Croatia adhere to 

the Hague Code of Conduct and are now 

North Atlantic Treaty Organization 

(NATO) allies. This revision will result 

in fewer license applications, because 

Albania and Croatia will now be eligible 

for License Exception APP. In addition, 

the EAR will no longer require NDAAbased recordkeeping and post shipment 

verification reporting of exports of high 

performance computers to Albania and 

Croatia (see Section 743.2 of the EAR). 

Section 734.4 ‘‘De minimis U.S. 

Content’’ 

Foreign-made computers with an APP 

of 0.75 WT located in a foreign country 

are not eligible for the application of the 

de minimis rules when they contain 

U.S.-origin controlled semiconductors 

(other than memory circuits) classified 

under ECCN 3A001 and are destined to 

a country in Computer Tier 3 of Section 

740.7 of the EAR. This rule increases the 

APP parameter from 0.75 WT to 1.5 WT 

in harmonization with the revision 

made to ECCN 4A003. 

Section 743.2 ‘‘High Performance 

Computers: Post Shipment Verification 

Reporting’’ 

This section outlines special postshipment reporting requirements for the 

export of certain computers to 

destinations in Computer Tier 3 of 

License Exception APP (Section 740.7 of 

the EAR). The reporting requirement 

applies to high performance computer 

exports to destinations in Computer Tier 

3, as well as exports of commodities 

used to enhance computers previously 

exported or reexported to Computer Tier 

3 destinations, where the APP is greater 

than 0.75 WT. This rule increases that 

APP level from 0.75 WT to 1.5 WT in 

accordance with the WA agreement to 

increase the APP level in ECCN 4A003. 

Export Administration Act 

Since August 21, 2001, the Export 

Administration Act of 1979, as 

amended, has been in lapse. However, 

the President has continued the EAR in 

effect under the International 

Emergency Economic Powers Act (50 

U.S.C. 1701–1707) through Executive 

Order 13222 of August 17, 2001 (3 CFR, 

2001 Comp. 783 (2002)), which has been 

extended by successive Presidential 

Notices, the most recent being that of 

August 12, 2010, 75 FR 50681 (August 

16, 2010). 

Rulemaking Requirements 

1. This final rule has been determined 

to be not significant for purposes of 

Executive Order 12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to, nor shall any person be 

subject to a penalty for failure to comply 

with a collection of information subject 

to the requirements of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.) (PRA), unless that collection of 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This rule 

involves two collections of information 

subject to the PRA. One of the 

collections has been approved by OMB 

under control number 0694–0088, 

‘‘Multi Purpose Application,’’ and 

carries a burden hour estimate of 43.8 

minutes for a manual or electronic 

submission. The other of the collections 

has been approved by OMB under 

control number 0694–0137, ‘‘’Licensing 

Exceptions and Exclusions,’’ and carries 

a burden hour estimate of 21 minutes 

for a manual or electronic submission. 

Send comments regarding these burden 

estimates or any other aspect of these 

collections of information, including 


jlentini on DSK4TPTVN1PROD with RULES
36988 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Rules and Regulations 

suggestions for reducing the burden, to 

OMB Desk Officer, New Executive 

Office Building, Washington, DC 20503; 

and to Jasmeet Seehra, OMB Desk 

Officer, by e-mail at 

Jasmeet_K._Seehra@omb.eop.gov or by 

fax to (202) 395–7285; and to the Office 

of Administration, Bureau of Industry 

and Security, Department of Commerce, 

14th and Pennsylvania Avenue, NW., 

Room 6622, Washington, DC 20230. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under Executive Order 

13132. 

4. The provisions of the 

Administrative Procedure Act (5 U.S.C. 

553) requiring notice of proposed 

rulemaking, the opportunity for public 

participation, and a delay in effective 

date, are inapplicable because this 

regulation involves a military and 

foreign affairs function of the United 

States (5 U.S.C. 553(a)(1)). Immediate 

implementation of these amendments 

fulfills the United States’ international 

obligation to the Wassenaar 

Arrangement on Export Controls for 

Conventional Arms and Dual Use Goods 

and Technologies. The Wassenaar 

Arrangement contributes to 

international security and regional 

stability by promoting greater 

responsibility in transfers of 

conventional arms and dual use goods 

and technologies, thus preventing 

destabilizing accumulations of such 

items. The Wassenaar Arrangement 

consists of 44 member countries that act 

on a consensus basis and the changes 

set forth in this rule implement 

agreements reached at the December 

2009 plenary session of the WA. 

Because the United States is a 

significant exporter of the items in this 

rule, implementation of this provision is 

necessary for the WA to achieve its 

purpose. Delaying implementation will 

create a disruption in the movement of 

affected items globally because of 

disharmony between export control 

measures implemented by WA 

members, resulting in tension between 

member countries. Export controls work 

best when all countries implement the 

same export controls in a timely 

manner. If this rulemaking was delayed 

to allow for notice and comment, it 

would prevent the United States from 

fulfilling its commitment to the WA in 

a timely manner and would injure the 

credibility of the United States in this 

and other multilateral regimes. 

Further, no other law requires that a 

notice of proposed rulemaking and an 

opportunity for public comment be 

given for this final rule. Because a 

notice of proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule under 

the Administrative Procedure Act or by 

any other law, the analytical 

requirements of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) are 

not applicable. Therefore, this 

regulation is issued in final form. 

Although there is no formal comment 

period, public comments on this 

regulation are welcome on a continuing 

basis. Comments should be submitted to 

Sharron Cook, Office of Exporter 

Services, Bureau of Industry and 

Security, Department of Commerce, 

14th and Pennsylvania Ave., NW., 

Room 2099, Washington, DC 20230. 

List of Subjects 

15 CFR Part 734 

Administrative practice and 

procedure, Exports, Inventions and 

patents, Research science and 

technology. 

15 CFR Part 740 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

15 CFR Part 743 

Administrative practice and 

procedure, Reporting and recordkeeping 

requirements. 

15 CFR Part 774 

Exports, Reporting and recordkeeping 

requirements. 

Accordingly, Parts 734, 740, 743 and 

774 of the Export Administration 

Regulations (15 CFR Parts 730 through 

774) are amended as follows: 

PART 734—[AMENDED] 

■ 1. The authority citation for Part 734 

continues to read as follows: 

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

U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 

3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 

FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 12, 2010, 75 

FR 50681 (August 16, 2010); Notice of 

November 4, 2010, 75 FR 68673 (November 

8, 2010). 

§ 734.4 [Amended] 

■ 2. Section 734.4 is amended by 

removing the phrase ‘‘0.75 Weighted 

TeraFLOPS (WT)’’ and adding in its 

place ‘‘1.5 Weighted TeraFLOPS (WT)’’ 

in paragraph (a)(1). 

PART 740—[AMENDED] 

■ 3. The authority citation for Part 740 

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. 7201 et seq.; 

E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., 

p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 12, 2010, 75 

FR 50681 (August 16, 2010). 

§ 740.7 [Amended] 

■ 4. Section 740.7 is amended by: 

■ a. Removing Albania and Croatia from 

the list of countries in paragraph (d)(1) 

and adding them in alphabetical order 

to paragraph (c)(1); 

■ b. Removing the number ‘‘0.5’’ and 

adding in its place ‘‘1.5’’ in paragraph 

(c)(3)(ii); and 

■ c. Removing the number ‘‘0.1’’ and 

adding in its place ‘‘0.5’’ in paragraph 

(d)(3)(i). 

PART 743—[AMENDED] 

■ 5. The authority citation for Part 743 

continues to read as follows: 

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

U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 

3 CFR, 2001 Comp., p. 783; Notice of August 

12, 2010, 75 FR 50681 (August 16, 2010). 

§ 743.2 [Amended] 

■ 6. Section 743.2 is amended by 

removing the phrase ‘‘0.75 Weighted 

TeraFLOPS (WT).’’ and adding in its 

place ‘‘1.5 Weighted TeraFLOPS (WT).’’ 

in paragraph (b). 

PART 774—[AMENDED] 

■ 7. The authority citation for Part 774 

continues to read as follows: 

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

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 

7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et 

seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 

42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 

1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22 

U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 12, 2010, 75 

FR 50681 (August 16, 2010). 

■ 8. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 

4—Computers, ECCN 4A003 is amended 

by revising the AT entry and Notes 1 

and 2 in the License Requirements 

section, and paragraph b. in the Items 

paragraphs of the List of Items 

Controlled section, to read as follows: 

Supplement No. 1 to Part 774—The 

Commerce Control List 

* * * * * 

4A003 ‘‘Digital computers’’, ‘‘electronic 

assemblies’’, and related equipment therefor, 

as follows and specially designed 

components therefor. 

License Requirements 

* * * * * 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Rules and Regulations 36989 

Control(s) Country 

chart 

* * * * * 

AT applies to entire entry .......

(refer to 4A994 for controls on 

‘‘digital computers’’ .............

with a APP > 0.0128 but ≤ to 

1.5 WT) ................................. AT Column 

1. 

* * * * * 

Note 1: For all destinations, except those 

countries in Country Group E:1 of 

Supplement No. 1 to part 740 of the EAR, no 

license is required (NLR) for computers with 

an ‘‘Adjusted Peak Performance’’ (‘‘APP’’) not 

exceeding 1.5 Weighted TeraFLOPS (WT) 

and for ‘‘electronic assemblies’’ described in 

4A003.c that are not capable of exceeding an 

‘‘Adjusted Peak Performance’’ (‘‘APP’’) 

exceeding 1.5 Weighted TeraFLOPS (WT) in 

aggregation, except certain transfers as set 

forth in § 746.3 (Iraq). 

Note 2: Special Post Shipment Verification 

reporting and recordkeeping requirements for 

exports of computers to destinations in 

Computer Tier 3 may be found in § 743.2 of 

the EAR. 

* * * * * 

List of Items Controlled 

* * * * * 

Items: 

* * * * * 

b. ‘‘Digital computers’’ having an 

‘‘Adjusted Peak Performance’’ (‘‘APP’’) 

exceeding 1.5 weighted TeraFLOPS (WT); 

* * * * * 

Dated: June 15, 2011. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2011–15842 Filed 6–23–11; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 50 

[Docket No. FDA–2003–N–0212; (formerly 

Docket No. 2003N–0355)] 

Medical Devices; Exception From 

General Requirements for Informed 

Consent 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

regulation to confirm, with one change, 

the interim final rule (IFR) entitled 

‘‘Medical Devices; Exception From 

General Requirements for Informed 

Consent.’’ This final rule confirms the 

IFR’s establishment of a new exception 

from the general requirements for 

informed consent to permit the use of 

investigational in vitro diagnostic 

devices to identify chemical, biological, 

radiological, or nuclear agents without 

informed consent in certain 

circumstances. FDA has created this 

exception to help ensure that 

individuals who may have been 

exposed to a chemical, biological, 

radiological, or nuclear agent are able to 

benefit from the timely use of the most 

appropriate diagnostic devices, 

including those that are investigational. 

This final rule adds a requirement that 

the investigator submit the required 

documentation to FDA, in addition to 

submitting it to the reviewing 

Institutional Review Board (IRB). 

DATES: The rule is effective June 24, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Claudia M. Gaffey, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5516, Silver Spring, 

MD 20993–0002, 301–796–6196. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Overview of Final Rule 

In the Federal Register of June 7, 2006 

(71 FR 32827), FDA published an 

Interim Final Rule that established an 

exception from the general requirements 

for informed consent to permit the use 

of investigational in vitro diagnostic 

devices to identify chemical, biological, 

radiological, or nuclear agents without 

informed consent in specified 

circumstances. The IFR amended 21 

CFR 50.23, to add paragraph (e). The 

rule was issued under the authority set 

forth in section 520(g)(3)(D) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360j(g)(3)(D)). 

FDA gave interested parties 60 days to 

comment on the IFR. FDA is publishing 

this final rule that incorporates one 

change in response to comments that 

the rule did not protect against misuse 

of the exception. This change is 

described in section II of this document. 

B. Legal Authority 

This regulation is being issued under 

the statutory authority provided in 

section 520(g)(3)(D) of the FD&C Act, 

which outlines the criteria under which 

an exemption from informed consent 

may be permissible. Under section 

520(g)(3)(D) of the FD&C Act, informed 

consent is required unless the 

investigator determines the following in 

writing: (1) There exists a life 

threatening situation involving the 

human subject of such testing which 

necessitates the use of such device; (2) 

it is not feasible to obtain informed 

consent from the subject; and (3) there 

is not sufficient time to obtain such 

consent from the subject’s legally 

authorized representative. Further, a 

licensed physician uninvolved in the 

testing must agree with this three-part 

determination in advance of using the 

device unless use of the device is 

required to save the life of the human 

subject of such testing and there is not 

sufficient time to obtain such 

concurrence. 

II. Highlights of Final Rule 

The preamble to the IFR described the 

provisions of this rule in detail (71 FR 

32827). In issuing this final rule, FDA is 

making one change to the IFR, in 

response to comments that the rule did 

not protect against misuse of this 

limited exception from informed 

consent requirements. In response to 

those concerns, FDA is adding a 

requirement that investigators also send 

the required documentation to FDA, not 

just to the reviewing IRB. This new 

requirement provides an additional 

level of oversight to help ensure that the 

limited exception criteria are met. 

III. Comments on the IFR 

The Agency received comments on 

the IFR from nine different entities. 

Comments were received from four 

individual consumers, two from 

consumer groups, and one each from a 

health professional, a health 

professional group, and a local 

government. A summary of the 

comments received, grouped by subject 

matter follows. 

A. General Comments 

(Comment 1) Three comments 

expressed support for the IFR, noting 

that the rule is needed and greatly 

improves the ability of public health 

laboratories to respond to a public 

health emergency. In contrast, six 

comments expressed general concern 

that the rule presents too much risk to 

the consumer. Some comments raised 

issues that are beyond the scope of this 

rulemaking. For example, one of these 

comments suggested that informed 

consent documents have a line 

addressing in vitro diagnostic testing; 

another encouraged the production of 

templates to easily provide the detailed 

information required to be included in 

the reports. 

(Response) FDA agrees with the 

comments recognizing that the rule will 

enable better response in public health 

emergencies. FDA also shares the 


jlentini on DSK4TPTVN1PROD with RULES