Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Rules and Regulations 30713 

consumer financial protection laws from 

the Board to the Bureau, effective July 

21, 2011, including TISA. The Bureau 

issued the Bureau Interim Final Rule to 

implement TISA in connection with the 

transfer of TISA rulemaking authority to 

the Bureau. Pursuant to section 1029 of 

the Dodd-Frank Act, however, the Board 

retains rulemaking authority for 

consumer financial protection laws to 

the extent that such laws could cover 

motor vehicle dealers identified in 

section 1029(a) of the Dodd-Frank Act. 

The Board does not believe that any 

motor vehicle dealers identified in 

section 1029(a) of the Dodd-Frank Act 

are or could become depository 

institutions engaged in activities that 

would be subject to the Board’s 

rulemaking authority under TISA. 

Consequently, the Board is repealing the 

Board’s Regulation DD, 12 CFR part 230. 

2. Summary of issues raised by 

comments in response to the initial 

regulatory flexibility analysis. The 

Board did not receive any comments on 

the initial regulatory flexibility analysis. 

3. Small entities affected by the final 

rule. The Board does not believe that 

any motor vehicle dealers identified in 

section 1029(a) of the Dodd-Frank Act 

are or could become depository 

institutions engaged in activities that 

would be subject to the Board’s 

rulemaking authority under TISA. 

Therefore, the Board believes the final 

rule would not affect any entity, 

including any small entity. 

4. Recordkeeping, reporting, and 

compliance requirements. The final rule 

repeals the Board’s Regulation DD, 12 

CFR part 230, and would therefore not 

impose any recordkeeping, reporting, or 

compliance requirements on any 

entities. 

5. Significant alternatives to the final 

revisions. Because the repeal of the 

Board’s Regulation DD (12 CFR part 

230) will have no impact, there are no 

significant alternatives that would 

further minimize the economic impact 

of the final rule on small entities. 

V. Paperwork Reduction Act 

In accordance with the Paperwork 

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

3506; 5 CFR Part 1320, Appendix A.1), 

the Board reviewed the rule under the 

authority delegated to the Federal 

Reserve by the Office of Management 

and Budget. The final rule contains no 

collections of information under the 

PRA. See 44 U.S.C. 3502(3). 

Accordingly, there is no paperwork 

burden associated with the final rule. 

List of Subjects in 12 CFR Part 230 

Advertising, Banks, Banking, 

Consumer protection, Reporting and 

recordkeeping requirements, Truth in 

savings. 

Authority and Issuance 

For the reasons set forth in the 

preamble, based on the transfer of 

authority under 12 U.S.C. 5581, the 

Board removes and reserves Regulation 

DD, 12 CFR part 230. 

PART 230—[REMOVED AND 

RESERVED] 

By order of the Board of Governors of the 

Federal Reserve System, May 22, 2014. 

Robert deV. Frierson, 

Secretary of the Board. 

[FR Doc. 2014–12356 Filed 5–28–14; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 748 

[Docket No. 140506409–4409–01] 

RIN 0694–AG15 

Amendments to Existing Validated 

End-User Authorizations in the 

People’s Republic of China: Samsung 

China Semiconductor Co. Ltd and 

Semiconductor Manufacturing 

International Corporation 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: In this rule, the Bureau of 

Industry and Security (BIS) amends the 

Export Administration Regulations 

(EAR) to revise existing authorizations 

for Validated End-Users (VEUs) 

Samsung China Semiconductor Co. Ltd. 

(Samsung China) and Semiconductor 

Manufacturing International 

Corporation (SMIC) in the People’s 

Republic of China (PRC). Specifically, 

BIS amends Supplement No. 7 to part 

748 of the EAR to change the address of 

the facility used by Samsung China. In 

addition, BIS adds a facility to the list 

of eligible destinations and an item to 

the list of eligible items for SMIC. 

DATES: This rule is effective May 29, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nies-Vogel, Chair, End-User 

Review Committee, Bureau of Industry 

and Security, U.S. Department of 

Commerce, 14th Street & Pennsylvania 

Avenue NW., Washington, DC 20230; by 

telephone: (202) 482–5991, fax: (202) 

482–3991, or email: ERC@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Authorization Validated End-User 

Validated End-Users (VEUs) are 

designated entities located in eligible 

destinations to which eligible items may 

be exported, reexported, or transferred 

(in-country) under a general 

authorization instead of a license. The 

names of the VEUs, as well as the dates 

they were so designated, and their 

respective eligible destinations and 

items are identified in Supplement No. 

7 to part 748 of the Export 

Administration Regulations (EAR). 

Under the terms described in that 

supplement, VEUs may obtain eligible 

items without an export license from the 

Bureau of Industry and Security (BIS), 

in conformity with Section 748.15 of the 

EAR. Eligible items vary between VEUs, 

but may include commodities, software, 

and technology, except those controlled 

for missile technology or crime control 

reasons on the Commerce Control List 

(CCL) (part 774 of the EAR). 

VEUs are reviewed and approved by 

the U.S. Government in accordance with 

the provisions of Section 748.15 and 

Supplement Nos. 8 and 9 to part 748 of 

the EAR. The End-User Review 

Committee (ERC), composed of 

representatives from the Departments of 

State, Defense, Energy, and Commerce, 

and other agencies, as appropriate, is 

responsible for administering the VEU 

program. BIS amended the EAR in a 

final rule published on June 19, 2007 

(72 FR 33646) to create Authorization 

VEU. 

Amendments to Existing Validated EndUser Authorizations in the People’s 

Republic of China (PRC) 

Revision to the List of ‘‘Eligible Items 

(By ECCN)’’ for Validated End-User 

Samsung China Semiconductor Co. Ltd 

(Samsung China) 

This final rule amends Supplement 

No. 7 to part 748 of the EAR to change 

the address of the Samsung China 

facility to which eligible items may be 

exported, reexported or transferred (incountry) using Authorization VEU. BIS 

makes this change pursuant to a request 

from Samsung China advising BIS that 

Samsung China received verification of 

the final address of its facility from the 

Chinese government. Samsung China’s 

VEU-eligible facility, which is located in 

an area being newly developed for 

corporate use, has not moved. The list 

of eligible items for Samsung China 

remains the same. BIS added Samsung 

China as a VEU in Supplement No. 7 to 

part 748 in a rule published in the 

Federal Register on July 10, 2013 (78 FR 

41291). 


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30714 Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Rules and Regulations 

Prior Address of Samsung China 

Destination: 

Samsung China Semiconductor Co. Ltd., 

Xinglong Street, Chang’an District, 

Xi’an, People’s Republic of China 

710065. 

New Address for Samsung China: 

Samsung China Semiconductor Co. Ltd., 

No. 1999, North Xiaohe Road, Xi’an, 

China 710119. 

Revisions to the List of ‘‘Eligible 

Destinations’’ and ‘‘Eligible Items (By 

ECCN)’’ for Validated End-User 

Semiconductor Manufacturing 

International Corporation (SMIC) 

This final rule also amends 

Supplement No. 7 to part 748 of the 

EAR to add a facility to the list of SMIC 

facilities to which eligible items may be 

exported, reexported or transferred (incountry) using Authorization VEU, 

bringing the number of SMIC’s VEUauthorized facilities in the PRC to a total 

of five. BIS also adds an ECCN to 

SMIC’s list of eligible items that may be 

sent to the five facilities. The ECCN 

added in this rule to SMIC’s VEU 

authorization is ECCN 3A233 (certain 

types of mass spectrometers). BIS makes 

these changes pursuant to requests from 

SMIC. SMIC requested the addition of 

the new VEU-eligible destination in 

order to facilitate shipments to its new 

business venture. 

Additional SMIC Destination: 

Semiconductor Manufacturing North 

China (Beijing) Corporation, No. 18 

Wen Chang Road, Building 9, Beijing 

Economic-Technological 

Development Area, Beijing, China 

100176. 

Eligible Items (by ECCN) That May Be 

Exported, Reexported or Transferred 

(In-Country) to the Eligible Destination 

Identified Under Semiconductor 

Manufacturing International 

Corporation Validated End-User 

Authorization 

ECCNs 1C350.c.3, 1C350.d.7, 2B006.b.1, 

2B230, 2B350.d.2, 2B350.d.3, 2B350.g.3, 

2B350.i.3, 3A233, 3B001.a, 3B001.b, 3B001.c, 

3B001.e, 3B001.f, 3C001, 3C002, 3C003, 

3C004, 5B002, and 5E002 (limited to 

‘‘technology’’ according to the General 

Technology Note for the ‘‘production’’ of 

integrated circuits controlled by ECCN 5A002 

that have been classified by BIS as eligible for 

License Exception ENC under paragraph 

(b)(2) or (b)(3) of Section 740.17 of the EAR, 

or classified by BIS as a mass market item 

under paragraph (b)(3) of Section 748.15 of 

the EAR). 

Authorization VEU eliminates the 

burden on exporters and reexporters of 

preparing individual license 

applications because the export, 

reexport and transfer (in-country) of the 

eligible items specified for each VEU 

may be made under general 

authorization instead of under 

individual licenses. 

Export Administration Act 

Since August 21, 2001, the Export 

Administration Act has been in lapse 

and the President, through Executive 

Order 13222 of August 17, 2001 (3 CFR, 

2001 Comp., p. 783 (2002)), as amended 

by Executive Order 13637 of March 8, 

2013, 78 FR 16129 (March 13, 2013), 

and as extended most recently by the 

Notice of August 8, 2013, 78 FR 49107 

(August 12, 2013), has continued the 

EAR in effect under the International 

Emergency Economic Powers Act. BIS 

continues to carry out the provisions of 

the Export Administration Act, as 

appropriate and to the extent permitted 

by law, pursuant to Executive Order 

13222, as amended by Executive Order 

13637. 

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, 

reducing costs, harmonizing rules, and 

promoting flexibility. This rule has been 

determined to be not significant for 

purposes of Executive Order 12866. 

2. This rule involves collections 

previously approved by the Office of 

Management and Budget (OMB) under 

Control Number 0694–0088, ‘‘MultiPurpose Application,’’ which carries a 

burden hour estimate of 43.8 minutes to 

prepare and submit form BIS–748; and 

for recordkeeping, reporting and review 

requirements in connection with 

Authorization VEU, which carries an 

estimated burden of 30 minutes per 

submission. This rule is expected to 

result in a decrease in license 

applications submitted to BIS. Total 

burden hours associated with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.) (PRA) and OMB 

Control Number 0694–0088 are not 

expected to increase significantly as a 

result of this rule. 

Notwithstanding any other provisions 

of law, no person is required to respond 

to, nor be subject to a penalty for failure 

to comply with a collection of 

information subject to the requirements 

of the PRA, unless that collection of 

information displays a currently valid 

OMB Control Number. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under Executive Order 

13132. 

4. Pursuant to the Administrative 

Procedure Act (APA), 5 U.S.C. 

553(b)(B), BIS finds good cause to waive 

requirements that this rule be subject to 

notice and the opportunity for public 

comment because they are unnecessary. 

In determining whether to grant VEU 

designations, a committee of U.S. 

Government agencies evaluates 

information about and commitments 

made by candidate companies, the 

nature and terms of which are set forth 

in 15 CFR part 748, Supplement No. 8. 

The criteria for evaluation by the 

committee are set forth in 15 CFR 

748.15(a)(2). 

The information, commitments, and 

criteria for this extensive review were 

all established through the notice of 

proposed rulemaking and public 

comment process (71 FR 38313 (July 6, 

2006) (proposed rule), and 72 FR 33646 

(June 19, 2007) (final rule)). Given the 

similarities between the authorizations 

provided under the VEU program and 

export licenses (as discussed further 

below), the publication of this 

information does not establish new 

policy. In publishing this final rule, BIS 

updates the address of an existing VEU 

and adds an eligible destination and an 

item to a second existing VEU. These 

changes have been made within the 

established regulatory framework of the 

Authorization VEU program. Further, 

this rule does not abridge the rights of 

the public or eliminate the public’s 

option to export under any of the forms 

of authorization set forth in the EAR. 

Publication of this rule in other than 

final form is unnecessary because the 

authorizations granted in the rule are 

consistent with the authorizations 

granted to exporters for individual 

licenses (and amendments or revisions 

thereof), which do not undergo public 

review. In addition, as with license 

applications, VEU authorization 

applications contain confidential 

business information, which is 

necessary for the extensive review 

conducted by the U.S. Government in 

assessing such applications. This 

information is extensively reviewed 

according to the criteria for VEU 

authorizations, as set out in 15 CFR 

748.15(a)(2). Additionally, just as the 

interagency reviews license 

applications, the authorizations granted 

under the VEU program involve 

interagency deliberation and result from 

review of public and non-public 

sources, including licensing data, and 


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Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Rules and Regulations 30715 

the measurement of such information 

against the VEU authorization criteria. 

Given the nature of the review, and in 

light of the parallels between the VEU 

application review process and the 

review of license applications, public 

comment on this authorization and 

subsequent amendments prior to 

publication is unnecessary. Moreover, 

because, as noted above, the criteria and 

process for authorizing and 

administering VEUs were developed 

with public comments, allowing 

additional public comment on this 

amendment to individual VEU 

authorizations, which was determined 

according to those criteria, is 

unnecessary. 

Section 553(d) of the APA generally 

provides that rules may not take effect 

earlier than thirty (30) days after they 

are published in the Federal Register. 

BIS finds good cause to waive the 30- 

day delay in effectiveness under 5 

U.S.C. 553(d)(3) because the delay 

would be contrary to the public interest. 

BIS is simply amending the list of VEU 

authorizations by adding a new end 

user, consistent with established 

objectives and parameters administered 

and enforced by the responsible 

designated departmental representatives 

to the End-User Review Committee. 

Delaying this action’s effectiveness 

could cause confusion regarding which 

facilitates and items are authorized by 

the U.S. Government and in turn stifle 

the purpose of the VEU Program. 

Accordingly, it is contrary to the public 

interest to delay this rule’s effectiveness. 

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 under the APA or by any other 

law, the analytical requirements of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) are not applicable. As a result, 

no final regulatory flexibility analysis is 

required and none has been prepared. 

List of Subjects in 15 CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

Dated: May 21, 2014. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

Accordingly, part 748 of the EAR (15 

CFR parts 730–774) is amended as 

follows: 

PART 748—[AMENDED] 

■ 1. The authority citation for 15 CFR 

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 8, 2013, 78 FR 49107 (August 12, 

2013). 

■ 2. Amend Supplement No. 7 to part 

748 by: 

■ a. Revising the the entry for ‘‘Samsung 

China Semiconductor Co. Ltd.’’ in 

‘‘China (People’s Republic of)’’; and 

■ b. Revising the entry for 

‘‘Semiconductor Manufacturing 

International Corporation’’ in ‘‘China 

(People’s Republic of)’’ to read as 

follows: 

SUPPLEMENT NO. 7 TO PART 748—AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, 

RESPECTIVE ITEMS ELIGIBLE FOR EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS

Country Validated 

end-user 

Eligible items 

(By ECCN) Eligible destination Federal Register citation 

Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited to § 748.15(c). 

*******

Samsung China Semiconductor Co. Ltd 1C350.c.3, 1C350.d.7, 2B230, 2B350.d.2, 

2B350.g.3, 2B350.i.3, 3A233, 3B001.a.1, 

3B001.b, 3B001.c, 3B001.e, 3B001.f, 3B001.h, 

3C002, 3C004, 3D002, and 3E001 (limited to 

‘‘technology’’ for items classified under 3C002 

and 3C004 and ‘‘technology’’ for use consistent with the International Technology 

Roadmap for Semiconductors process for 

items classified under ECCNs 3B001 and 

3B002). 

Samsung China Semiconductor Co. Ltd., No. 

1999, North Xiaohe Road, Xi’an, China 

710119. 

78 FR 41291, 7/10/13. 

78 FR 69535, 11/20/13. 

79 FR [INSERT PAGE 

NUMBER], 5/29/14. 

Semiconductor Manufacturing International 

Corporation.

1C350.c.3, 1C350.d.7, 2B006.b.1, 2B230, 

2B350.d.2, 2B350.d.3, 2B350.g.3, 2B350.i.3, 

3A233, 3B001.a, 3B001.b, 3B001.c, 3B001.e, 

3B001.f, 3C001, 3C002, 3C003, 3C004, 

5B002, and 5E002 (limited to ‘‘technology’’ according to the General Technology Note for 

the ‘‘production’’ of integrated circuits controlled by ECCN 5A002 that have been classified by BIS as eligible for License Exception 

ENC under paragraph (b)(2) or (b)(3) of Section 740.17 of the EAR, or classified by BIS as 

a mass market item under paragraph (b)(3) of 

Section 748.15 of the EAR). 

Semiconductor Manufacturing International 

(Shanghai) Corporation, 18 Zhang Jiang Rd., 

Pudong New Area, Shanghai, China 201203. 

Semiconductor Manufacturing International 

(Tianjin) Corporation, 19 Xing Hua Avenue, Xi 

Qing Economic Development Area, Tianjin, 

China 300385. 

Semiconductor Manufacturing International (Beijing) Corporation, No. 18 Wen Chang Road, 

Beijing Economic-Technological Development 

Area, Beijing, China 100176. 

Semiconductor Manufacturing International 

(Shenzhen) Corporation, Qier Road, Export 

Processing Zone, Pingshan New Area, 

Shenzhen, China 518118. 

72 FR 59164, 10/19/07. 

75 FR 67029, 11/1/10. 

77 FR 10953, 2/24/12. 

78 FR 69535, 11/20/13. 

79 FR [INSERT PAGE 

NUMBER], 5/29/14. 

Semiconductor Manufacturing North China (Beijing) Corporation, No. 18 Wen Chang Road, 

Building 9, Beijing Economic-Technological 

Development Area, Beijing, China 100176. 

* * * * * * * 


emcdonald on DSK67QTVN1PROD with RULES
30716 Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Rules and Regulations 

[FR Doc. 2014–12158 Filed 5–28–14; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1 and 16 

[Docket No. FDA–2013–N–0365] 

Administrative Detention of Drugs 

Intended for Human or Animal Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

implementing administrative detention 

authority with respect to drugs intended 

for human or animal use as authorized 

by amendments made to the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA). FDA’s administrative 

detention authority with respect to 

drugs allows FDA to better protect the 

integrity of the drug supply chain. 

Specifically, FDA is able to 

administratively detain drugs 

encountered during an inspection that 

an authorized FDA representative 

conducting an inspection has reason to 

believe are adulterated or misbranded. 

This authority is intended to protect the 

public by preventing distribution or 

subsequent use of drugs encountered 

during inspections that are believed to 

be adulterated or misbranded, until FDA 

has had time to consider what action it 

should take concerning the drugs, and 

to initiate legal action, if appropriate. 

DATES: This rule is effective June 30, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Charlotte Hinkle, Office of Regulatory 

Affairs, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 4343, Silver Spring, MD 20993– 

0002, 301–796–5300, 

FDASIAImplementationORA@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Purpose of the Regulatory Action 

FDA’s administrative detention 

authority with respect to drugs intended 

for human or animal use allows FDA to 

better protect the integrity of the drug 

supply chain. Specifically, 

administrative detention is intended to 

protect the public by preventing 

distribution or subsequent use of drugs 

encountered during inspections that 

may be adulterated or misbranded, until 

FDA has had time to consider what 

action it should take concerning the 

drugs, and to initiate legal action, if 

appropriate. FDA already has the 

authority to administratively detain 

devices, tobacco, and foods that FDA 

has reason to believe are adulterated or 

misbranded. 

FDA is issuing this final rule under 

section 304(g) of the FD&C Act (21 

U.S.C. 334(g)), as amended by section 

709 of FDASIA, and section 701 of the 

FD&C Act (21 U.S.C. 371). Section 

304(g) of the FD&C Act also authorizes 

FDA to administratively detain devices 

and tobacco products. 

Summary of the Major Provisions 

This final rule implements a 

regulation for the administrative 

detention of drugs. FDA is amending 

parts 1 and 16 (21 CFR parts 1 and 16) 

to create an implementing rule for this 

authority. The changes set forth the 

procedures for detention of drugs 

believed to be adulterated or 

misbranded and amend the scope of 

FDA’s part 16 regulatory hearing 

procedures to include the 

administrative detention of drugs. 

Costs and Benefits 

The primary public health benefits 

from adoption of the final rule would be 

the value of the illnesses or deaths 

prevented because the Agency 

administratively detained a drug it has 

reason to believe is adulterated or 

misbranded; this benefit occurs only if 

the drug would not have been prevented 

from entering the market using one of 

the Agency’s other enforcement tools. 

The estimated primary costs to FDA 

include marking or labeling the 

detained product and costs associated 

with appeals of detention orders. The 

Agency estimates the net annual social 

costs to be between $0 and $602,602. 

I. Background 

In the Federal Register of July 15, 

2013 (78 FR 42381), FDA proposed 

regulations to implement its new 

authority to administratively detain 

drugs that an authorized FDA 

representative conducting an inspection 

under section 704 of the FD&C Act (21 

U.S.C. 374) has reason to believe are 

adulterated or misbranded. As 

discussed in the preamble to the 

proposed rule, on July 9, 2012, 

President Obama signed into law 

FDASIA (Public Law 112–144). Title VII 

of FDASIA provides FDA with 

important new authorities to help it 

better protect the integrity of the drug 

supply chain. One of those new 

authorities is section 709, which 

amends section 304(g) of the FD&C Act 

to provide FDA with administrative 

detention authority with respect to 

drugs. Section 304(g) of the FD&C Act, 

as amended by FDASIA, provides FDA 

the same authority to detain drugs that 

section 304(g) already provides FDA 

with respect to devices and tobacco 

products. Once these implementing 

regulations with respect to drugs take 

effect, the amendments to section 304(g) 

of the FD&C Act will allow FDA to 

administratively detain drugs that an 

authorized FDA representative 

conducting an inspection under section 

704 of the FD&C Act has reason to 

believe are adulterated or misbranded, 

until FDA has had time to consider 

what action it should take concerning 

the drugs, and to initiate legal action, if 

appropriate. 

II. Overview of the Final Rule Including 

Changes to the Proposed Rule 

A. Revisions to Part 1 

FDA is amending title 21 of the Code 

of Federal Regulations, part 1 to create 

an implementing regulation for the 

administrative detention of drugs. The 

amendment to part 1 consists of one 

section, § 1.980, under a new subpart, 

which is titled ‘‘Subpart Q— 

Administrative Detention of Drugs 

Intended for Human or Animal Use.’’ 

Section 1.980 sets forth the procedures 

for the administrative detention of drugs 

encountered during an inspection that 

are believed to be adulterated or 

misbranded. The new regulation is 

closely modeled on the current 

regulation for the administrative 

detention of devices (21 CFR 800.55). 

There are minor differences from the 

device regulation, including updates to 

statutory references to refer to drugs 

instead of devices and changes to 

language to conform to current Federal 

Register requirements. Since FDA 

issued the proposed rule on 

administrative detention of drugs, FDA 

has issued other regulations in part 1, 

requiring reassignment of the section 

number within part 1. No other changes 

have been made to the substance of the 

proposed regulation. Other than 

renumbering the section, FDA is 

finalizing the implementing regulations 

as proposed. 

B. Revisions to Part 16 

The amendment to part 16 is a 

technical change. This change amends a 

statement in § 16.1 so that the scope of 

part 16 regulatory hearing procedures 

also will include administrative 


emcdonald on DSK67QTVN1PROD with RULES