58396 Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Rules and Regulations 

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

12, 2011, 76 FR 50661 (August 16, 2011). 

PART 760—[AMENDED] 

■ 18. The authority citation for 15 CFR 

part 760 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 762—[AMENDED] 

■ 19. The authority citation for 15 CFR 

part 762 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 764—[AMENDED] 

■ 20. The authority citation for 15 CFR 

part 764 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 766—[AMENDED] 

■ 21. The authority citation for 15 CFR 

part 766 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 768—[AMENDED] 

■ 22. The authority citation for 15 CFR 

part 768 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 770—[AMENDED] 

■ 23. The authority citation for 15 CFR 

part 770 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 772—[AMENDED] 

■ 24. The authority citation for 15 CFR 

part 772 is revised 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, 2011, 76 FR 50661 (August 16, 2011). 

PART 774—[AMENDED] 

■ 25. The authority citation for 15 CFR 

part 774 is revised 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, 2011, 76 

FR 50661 (August 16, 2011). 

Dated: September 15, 2011. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2011–24227 Filed 9–20–11; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Parts 743, 748, 772, and 774 

[Docket No. 100325169–0629–01] 

RIN 0694-AE90 

Editorial Correction to the Export 

Administration Regulations 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: This final rule corrects 

reference and typographical errors in 

the Export Administration Regulations 

(EAR). The corrections are editorial in 

nature and do not affect license 

requirements. In addition to the 

editorial corrections, this rule adds new 

definitions to the EAR that were 

inadvertently not incorporated by a 

previous rule. 

DATES: Effective on September 21, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Sharron Cook, Office of Exporter 

Services, Bureau of Industry and 

Security, by telephone (202) 482–4890 

or e-mail: Sharron.cook@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: This final 

rule updates five parts of the EAR and 

two categories of the Commerce Control 

List (CCL). Three parts of the EAR are 

updated to correct internal references 

and subsection designations, and the 

supplement to another part is updated 

to provide a complete and more 

accurate description of controls and the 

related items on the CCL. In addition, 

this rule adds definitions to another part 

of the EAR to harmonize it with the 

Wassenaar Arrangement on Export 

Controls for Conventional Arms and 

Dual-Use Goods and Technologies. 

Part 743 

This document revises a paragraph 

designation in the final rule that was 

published by BIS on May 22, 2009 (74 

FR 23941, 23947). More specifically, the 

last paragraph of Section 743.3 was 

designated inconsistent with the 

section’s alphabetical order. To use the 

appropriate alphabetical designation, 

this document redesignates the last 

paragraph (d) in Section 743.3 as (f). 

This change ensures that all relevant 

paragraphs in Section 743.3 are properly 

and consistently designated. 

Part 748 

This document revises the 

designation of a subparagraph in the 

final rule that was published by BIS on 

March 25, 1996 (61 FR 12812, 12829). 

The March 25, 1996 rule redesignated 

some paragraphs in Supplement No. 5 

to part 748, but failed to redesignate the 

paragraph following (a)(6)(vi)(B)(2), 

which is designated (iii), as (a)(6)(vi)(C). 

This rule provides the correct 

designation, thereby ensuring that all 

relevant paragraphs in Supplement No. 

5 to Part 748 are properly designated. 

Part 772 

This final rule adds two definitions to 

part 772 of the EAR to harmonize with 

definitions found in the list of terms 

that accompanies the Wassenaar 

Arrangement list of dual-use items and 

to ensure consistency within the EAR 

where these definitions are used. More 

specifically, the two definitions, 

‘‘Communications Channel Controller’’ 

and ‘‘Network Access Controller’’ are 

added to Category 4 of the CCL. The 

addition of the terms to part 772 will 

ensure consistency. 

Supplement No. 1 to Part 774 

This rule revises entries on the CCL 

to provide a complete and more 

accurate description of controls in 

certain Export Control Classification 

Numbers (ECCNs). Specific 

amendments applying to ECCNs 3A001 

and Notes of Category 5 part 2 of the 

CCL are described below. 

Category 3 Electronics 

ECCN 3A001.g is amended by adding 

a Technical Note that was removed on 

October 14, 2009. 

Category 5, Part 2 Information Security 

The introductory section of this 

Category is amended by adding 

‘‘Technical Note: Parity bits are not 

included in the key length,’’ because 

this Note was inadvertently removed 

from its previous place within ECCN 

5A002. However, to remain consistent 

with the Wassenaar Arrangement and 

because this note regarding parity bits 

applies to all Category 5, part 2 ECCNs, 

BIS is including the additional language 


wreier-aviles on DSK7SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Rules and Regulations 58397 

at the end of the Notes that appear 

before the beginning of 5A002. 

Rulemaking Requirements 

1. Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been designated a ‘‘not significant 

regulatory action,’’ under section 3(f) 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 Paperwork 

Reduction Act, unless that collection of 

information displays a currently valid 

Office of Management and Budget 

Control Number. This rule does not 

affect any paperwork collection. This 

rule does not contain policies with 

Federalism implications as that term is 

defined under E.O. 13132. 

3. The Department finds that there is 

good cause under 5 U.S.C. 553(b)(3)(B) 

to waive the provisions of the 

Administrative Procedure Act requiring 

prior notice and the opportunity for 

public comment because they are 

unnecessary. The revisions made by this 

rule are administrative in nature and do 

not affect the rights and obligations of 

the public. Because these revisions are 

not substantive changes to the EAR, it 

is unnecessary to provide notice and 

opportunity for public comment. In 

addition, the 30-day delay in 

effectiveness required by 5 U.S.C. 553(d) 

is not applicable because this rule is not 

a substantive rule. No other law requires 

that a notice of proposed rulemaking 

and opportunity for public comment be 

given for this rule. The analytical 

requirements of the Regulatory 

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

not applicable. 

List of Subjects 

CFR Part 743 

Administrative practice and 

procedure, Reporting and recordkeeping 

requirements. 

CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

CFR Part 772 

Exports. 

CFR Part 774 

Exports, Reporting and recordkeeping 

requirements. 

Accordingly, parts 743, 748, 772 and 

774 of the EAR (15 CFR parts 730–774) 

are amended as follows: 

PART 743—[AMENDED] 

■ 3. 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, 2011, 76 FR 50661 (August 16, 2011). 

■ 4. Section 743.3 is amended by 

redesignating paragraph (d) following 

paragraph (e) as paragraph (f). 

PART 748—[AMENDED] 

■ 5. The authority citation for part 748 

continues to read as follows: 

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

U.S.C. 1701 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, 2011, 76 FR 50661 (August 16, 

2011). 

Supplement No. 5 to Part 748— 

[Amended] 

■ 6. Supplement No. 5 to part 748 is 

amended by redesignating paragraph 

(iii) that follows paragraph 

(a)(6)(vi)(B)(2) as paragraph (a)(6)(vi)(C). 

Part 772—[AMENDED] 

■ 7. The authority citation for part 772 

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, 2011, 76 FR 50661 (August 16, 2011). 

■ 8. Section 772.1 is amended by adding 

the definitions ‘‘Communications 

Channel Controller’’ and ‘‘Network 

Access Controller’’ in alphabetical order 

to read as follows: 

§ 772.1 Definitions of terms as used in the 

Export Administration Regulations (EAR). 

* * * * * 

Communications Channel Controller. 

(Cat 4)—The physical interface which 

controls the flow of synchronous or 

asynchronous digital information. It is 

an assembly that can be integrated into 

computer or telecommunications 

equipment to provide communications 

access. 

* * * * * 

Network Access Controller. (Cat 4)—A 

physical interface to a distributed 

switching network. It uses a common 

medium which operates throughout at 

the same ‘‘digital transfer rate’’ using 

arbitration (e.g., token or carrier sense) 

for transmission. Independently from 

any other, it selects data packets or data 

groups (e.g., IEEE 802) addressed to it. 

It is an assembly that can be integrated 

into computer or telecommunications 

equipment to provide communications 

access. 

* * * * * 

Part 774—[AMENDED] 

■ 9. 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, 2011, 76 

FR 50661 (August 16, 2011). 

■ 10. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 3 

Electronics, ECCN 3A001 is amended by 

adding a technical note after the Note 2 

of paragraph g.2.b in the Items 

paragraph of the List of Items Controlled 

section to read as follows: 

Supplement No. 1 to Part 774— 

Commerce Control List 

* * * * * 

3A001 Electronic components and 

specially designed components therefor, as 

follows (see List of Items Controlled). 

* * * * * 

List of Items Controlled 

* * * * * 

Items: 

* * * * * 

g. * * * 

g.2. * * * 

g.2.b. * * * 

Technical Note: For the purposes of 

3A001.g, a ‘‘thyristor module’’ contains one 

or more thyristor devices. 

* * * * * 

■ 11. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 5, 

Telecommunications and ‘‘Information 

Security,’’ Part II Information Security, 

is amended by adding a Technical Note 

to the end of the notes appearing at the 

beginning of the Category, to read as 

follows: 

Category 5—Telecommunications and 

‘‘Information Security’’ 

Part II. ‘‘Information Security’’ 

* * * * * 


wreier-aviles on DSK7SPTVN1PROD with RULES
58398 Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Rules and Regulations 

Technical Note: Parity bits are not 

included in the key length. 

* * * * * 

Dated: September 15, 2011. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2011–24229 Filed 9–20–11; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2011-D–0633] 

Revised Guidance on Marketed 

Unapproved Drugs; Compliance Policy 

Guide Sec. 440.100; Marketed New 

Drugs Without Approved NDAs or 

ANDAs; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of compliance policy 

guide. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised guidance 

entitled ‘‘Marketed Unapproved Drugs— 

Compliance Policy Guide Sec. 440.100, 

Marketed New Drugs Without Approved 

NDAs or ANDAs’’ (CPG 440.100). CPG 

440.100 describes how FDA intends to 

exercise its enforcement discretion with 

regard to drug products marketed in the 

United States that do not have required 

FDA approval for marketing. CPG 

440.100 has been revised to state that 

the enforcement priorities and potential 

exercise of enforcement discretion 

discussed in the CPG apply only to 

unapproved new drug products that are 

being commercially used or sold as of 

September 19, 2011. All unapproved 

new drugs introduced onto the market 

after that date are subject to immediate 

enforcement action at any time, without 

prior notice and without regard to the 

enforcement priorities set forth in CPG 

440.100. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sakineh Walther, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002, 301– 

796–3349. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised guidance entitled ‘‘Marketed 

Unapproved Drugs—Compliance Policy 

Guide Sec. 440.100, Marketed New 

Drugs Without Approved NDAs or 

ANDAs’’. This CPG is being issued 

consistent with FDA’s good guidance 

practices (GGP) regulation (§ 10.115 (21 

CFR 10.115)). This CPG is being 

implemented without prior public 

comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (§ 10.115(g)(2)). The Agency 

made this determination because, in 

light of the fact that revised CPG 

440.100 establishes the date after which 

the enforcement priorities and potential 

exercise of enforcement discretion 

discussed in it do not apply to newly 

introduced unapproved drugs, delayed 

implementation of revised CPG 440.100 

would provide an incentive for 

manufacturers to rush new unapproved 

drugs to market during the comment 

and finalization period, in order to be 

subject to enforcement priorities that 

may be perceived as more advantageous 

to extended marketing of illegal, 

unapproved drug products. The 

potential increase in marketing of new 

unapproved drugs raises public health 

concerns; because unapproved drug 

products have not been approved by 

FDA for safety, effectiveness, and 

quality, patients may be at greater risk 

when using unapproved drug products 

than when using FDA-approved drug 

products. In light of the concerns about 

potential increased marketing of new 

unapproved drugs, FDA has determined 

that it is not appropriate to seek 

comment before implementing revised 

CPG 440.100. Although CPG 440.100 is 

immediately in effect, it remains subject 

to comment in accordance with the 

Agency’s GGP regulation. 

Under the Federal Food, Drug, and 

Cosmetic Act, drug products that 

require approval must obtain that 

approval prior to introduction into 

interstate commerce (see 21 U.S.C. 355). 

Manufacturers and distributors of 

products that enter the market without 

complying with these long-standing 

statutory requirements are acting in 

violation of the law. In June 2006, FDA 

announced a new drug safety initiative 

to remove unapproved drugs from the 

market. As part of the Unapproved 

Drugs Initiative, FDA issued a final CPG 

entitled ‘‘Marketed Unapproved Drugs— 

Compliance Policy Guide Sec. 440.100, 

Marketed New Drugs Without Approved 

NDAs or ANDAs’’ (CPG 440.100) (see 71 

FR 33466, June 9, 2006). CPG 440.100 

describes how FDA intends to exercise 

its enforcement discretion regarding 

currently marketed unapproved new 

drugs. CPG 440.100 describes six 

categories of unapproved drug products 

that are the Agency’s highest 

enforcement priorities, and the 

circumstances in which the Agency 

intends to bring enforcement actions 

consistent with those priorities. FDA 

has initiated 17 actions against 

unapproved new drugs under the 

Unapproved Drugs Initiative and 

engaged in significant outreach to 

manufacturers, distributors, consumers 

and prescribers under this Initiative, 

resulting in the removal of over a 

thousand unapproved new drugs from 

the market (see http://www.fda.gov/ 

Drugs/GuidanceComplianceRegulatory

Information/EnforcementActivities

byFDA/SelectedEnforcementActionson

UnapprovedDrugs/ucm238675.htm). 

Despite both the long-standing 

statutory requirement that new drugs 

must obtain approval prior to marketing 

(21 U.S.C. 355) and FDA’s outreach 

efforts under the Marketed Unapproved 

Drugs Initiative, FDA is aware that 

unapproved new drugs have continued 

to come onto the market after the 

issuance of the 2006 CPG. In some 

cases, these unapproved new drugs 

come onto the market to compete with 

other unapproved new drugs that are 

already on the market. In other cases, 

unapproved new drugs are introduced 

to the market when a manufacturer 

perceives that there may be an 

‘‘opportunity’’ to gain a share of the 

market after actions taken by FDA, 

including enforcement actions that 

remove similar unapproved new drugs 

from the market. In either case, FDA 

must expend additional scarce resources 

to address unapproved products in 

situations where manufacturers and 

distributors have had ample notice that 

the products they are introducing onto 


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