68200 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations 

by adding the entry for § 665.20 in 

numerical order to read as follows: 

§ 902.1 OMB control numbers assigned 

pursuant to the Paperwork Reduction Act. 

* * * * * 

(b) * * * 

CFR part or section where the information collection requirement is located Current OMB control No. 

(all numbers begin with 0648–) 

*******

50 CFR ............................................................................................................................................................ ............................................................

* * * * * * * 

665.20 .............................................................................................................................................................. –0612 

*******

[FR Doc. 2010–28075 Filed 11–4–10; 8:45 am] 

BILLING CODE 3510–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 892 

[Docket No. FDA–2008–N–0273] 

Medical Devices; Radiology Devices; 

Reclassification of Full-Field Digital 

Mammography System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

reclassification of the full-field digital 

mammography (FFDM) system from 

class III (premarket approval) to class II 

(special controls). The device type is 

intended to produce planar digital x-ray 

images of the entire breast; this generic 

type of device may include digital 

mammography acquisition software, 

full-field digital image receptor, 

acquisition workstation, automatic 

exposure control, image processing and 

reconstruction programs, patient and 

equipment supports, component parts, 

and accessories. The special control that 

will apply to the device is the guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: FullField Digital Mammography System.’’ 

FDA is reclassifying the device into 

class II (special controls) because 

general controls along with special 

controls will provide a reasonable 

assurance of safety and effectiveness of 

the device. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of the 

guidance document that will serve as 

the special control for this device. 

DATES: This rule is effective December 6, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Mary Pastel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. G304, 

Silver Spring, MD 20993–0002, 301– 

796–6887; or 

Kyle J. Myers, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 62, rm. 3118, 

Silver Spring, MD 20993–0002, 301– 

796–2533. 

SUPPLEMENTARY INFORMATION: 

I. Statutory Framework for Device 

Classification 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 301 et 

seq.), as amended by the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

the Safe Medical Devices Act of 1990 

(Pub. L. 101–629), the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115), and 

the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), among other amendments, 

established a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, depending on the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the FD&C Act, 

FDA refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as ‘‘preamendments 

devices.’’ FDA classifies these devices 

after the Agency has taken the following 

steps: 

1. Receives a recommendation from a 

device classification panel (an FDA 

advisory committee); 

2. Publishes the panel’s 

recommendation for comment, along 

with a proposed regulation classifying 

the device; and 

3. Publishes a final regulation 

classifying the device type. 

FDA has classified most 

preamendments devices under these 

procedures. 

FDA refers to devices that were not in 

commercial distribution before May 28, 

1976, as ‘‘postamendments devices.’’ 

These devices are classified 

automatically by statute (section 513(f) 

of the FD&C Act) into class III without 

any FDA rulemaking process. These 

device types remain in class III and 

require premarket approval, unless and 

until: 

1. FDA reclassifies the device type 

into class I or II; 

2. FDA issues an order classifying the 

device type into class I or II in 

accordance with section 513(f)(2) of the 

FD&C Act, as amended by FDAMA; or 

3. FDA issues an order finding the 

device to be substantially equivalent, 

under section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. The Agency 

determines whether new devices are 

substantially equivalent to predicate 

devices by means of premarket 

notification procedures in section 510(k) 

of the FD&C Act (21 U.S.C. 360(k)) and 

21 CFR part 807 of the regulations. 

Reclassification of classified 

postamendments devices is governed by 

section 513(f)(3) of the FD&C Act. This 

section provides that FDA may initiate 

the reclassification of a device classified 

into class III under section 513(f)(1) of 

the FD&C Act, or the manufacturer or 

importer of a device may petition the 

Secretary of Health and Human Services 

(the Secretary) for the issuance of an 

order classifying the device into class I 

or class II. FDA’s regulations in 21 CFR 

860.134 set forth the procedures for the 

filing and review of a petition for 

reclassification of these class III devices. 

To change the classification of the 

device, the proposed new class must 

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Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations 68201 

have sufficient regulatory controls to 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. 

Under section 513(f)(3)(B)(i) of the 

FD&C Act, the Secretary may ask for a 

recommendation from a device 

classification panel on a proposed 

reclassification, whether initiated by 

FDA or a petitioner. The panel will 

make a recommendation to FDA 

concerning the proposed 

reclassification. The recommendation 

must contain the following information: 

(1) A summary of the reasons for the 

recommendation, (2) a summary of the 

data upon which the recommendation is 

based, and (3) an identification of the 

risks to health (if any) presented by the 

device that is the subject of the 

proposed reclassification. 

Following the effective date of this 

final rule, any firm submitting a 510(k) 

for an FFDM system will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness. 

II. Regulatory History of the Device 

An FFDM system is a 

postamendments device classified into 

class III under section 513(f)(1) of the 

FD&C Act. This generic type of device 

cannot be placed in commercial 

distribution unless it is reclassified 

under section 513(f)(3) of the FD&C Act 

or subject to an approval of a premarket 

approval (PMA) application under 

section 515 of the FD&C Act (21 U.S.C. 

360e). In accordance with section 

513(f)(3) of the FD&C Act and based on 

information regarding the device, FDA, 

on its own initiative, is reclassifying this 

device type from class III to class II 

when intended to produce planar digital 

x-ray images of the entire breast. This 

generic type of device may include 

digital mammography acquisition 

software, full-field digital image 

receptor, acquisition workstation, 

automatic exposure control, image 

processing and reconstruction programs, 

patient and equipment supports, 

component parts, and accessories. 

Consistent with the FD&C Act and the 

regulation, FDA referred the proposed 

reclassification to the Radiological 

Devices Panel (the Panel) for its 

recommendation on the requested 

change in classification. 

At a public meeting on May 23, 2006, 

the Panel unanimously recommended 

that the FFDM system be reclassified 

from class III to class II (special 

controls). The Panel believed that class 

II with a special controls guidance 

document, in addition to general 

controls, would provide reasonable 

assurance of the safety and effectiveness 

of the device (Ref. 1). 

Accordingly, in the Federal Register 

of May 30, 2008 (73 FR 31040), FDA 

issued a proposed rule to reclassify the 

device, full-field digital mammography 

system, from class III (premarket 

approval) into class II (special controls). 

FDA invited interested persons to 

comment on the proposed rule by 

August 28, 2008. 

A second meeting of the Panel was 

held on November 17, 2009. This 

meeting was called because the 

comments received on the proposed 

rule raised the following new questions: 

Are separate data needed to demonstrate 

the equivalence of FFDM for screening 

and diagnosis indications? Are 

statistically significant clinical studies 

needed to demonstrate equivalence or 

can equivalence be demonstrated with 

laboratory and phantom studies along 

with limited clinical demonstrations? 

Are clinical data on various subgroups 

necessary to demonstrate equivalence? 

The Panel unanimously 

recommended that the FFDM system be 

reclassified from class III to class II 

(special controls). The Panel also 

indicated that separate data are 

necessary for screening and diagnostic 

claims; that laboratory and phantom 

studies with limited clinical 

demonstration are adequate to establish 

equivalence; and that subcategory 

analysis is unnecessary. 

III. Summary of Final Rule 

The final rule contains revisions to 

the identification of the device type, 

FFDM system in the draft classification 

regulation, 21 CFR 892.1715. The final 

rule uses the term ‘‘planar’’ instead of 

‘‘full-field’’ to describe digital x-ray 

images of the entire breast. The sentence 

stating what the generic type of device 

may include was revised by adding 

automatic exposure control, image 

processing and reconstruction programs, 

patient and equipment supports, 

component parts, and accessories, and 

by eliminating signal analysis programs. 

This change was made to clarify the 

description by explicitly listing aspects 

of the device and excluding signal 

analysis programs that are contained 

within the display devices, which are 

regulated separately. Display devices are 

not part of the FFDM system but rather 

are separate class II devices. The 

identification now reads: Intended to 

produce planar digital x-ray images of 

the entire breast. This generic type of 

device may include digital 

mammography acquisition software, 

full-field digital image receptor, 

acquisition workstation, automatic 

exposure control, image processing and 

reconstruction programs, patient and 

equipment supports, component parts, 

and accessories. 

IV. Comments and FDA’s Response 

During the public comment period, 23 

respondents submitted comments. The 

comments included manufacturers, 

professional organizations, trade 

associations, and individual medical 

professionals. All comments supported 

the reclassification of the FFDM system 

from class III (premarket approval) to 

class II (special controls). 

(Comment 1) One comment suggested 

that the identification’s use of the term 

‘‘signal analysis’’ can be confusing in the 

context of FFDM systems and suggested 

that some items were not completely 

incorporated into the FFDM 

identification from the film/screen 

identification that should have been 

incorporated for clarity. The comment 

suggested that the regulation use the 

following identification to address those 

concerns: A full-field digital 

mammography system is a device 

intended to produce full-field digital 

x-ray images of the breast. This generic 

type of device may include one or more 

of the following: Digital mammography 

acquisition software, full-field digital 

image receptor, acquisition workstation, 

automatic exposure control, and image 

processing and reconstruction programs, 

patient and equipment supports, 

component parts, and accessories. 

(Response) FDA agrees with the 

comment and has revised the 

identification to be similar to the 

language suggested by the comment. 

V. FDA’s Conclusions 

Based on the information discussed in 

the preamble to the proposed rule (73 

FR 31040) and comments on the 

proposed rule and draft special controls 

guidance, FDA concludes that special 

controls, in addition to general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the full-field 

digital mammography system. The 

Agency is reclassifying the full-field 

digital mammography system from class 

III (premarket approval) to class II 

(special controls) when intended to 

produce planar digital x-ray images of 

the entire breast. This generic type of 

device may include digital 

mammography acquisition software, 

full-field digital image receptor, 

acquisition workstation, automatic 

exposure control, image processing and 

reconstruction programs, patient and 

equipment supports, component parts, 

and accessories. 

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68202 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Full-Field Digital 

Mammography System’’ that the Agency 

intends to use as the special control for 

this device. The guidance addresses the 

information FDA believes should be 

included in a premarket notification 

submission (510(k)) for the FFDM 

system. FDA has identified the risks to 

health associated with the use of the 

device in the first column of table 1 of 

the special controls guidance document. 

The recommended mitigation measures 

are identified in the second column of 

table 1 of the special controls guidance 

document. 

VI. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) 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. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

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 classification of this 

device into class II will relieve 

manufacturers of the cost of complying 

with the premarket approval 

requirements of section 515 of the FD&C 

Act and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, 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 $135 million, using the 

most current (2009) 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. 

FFDM devices are intended to 

produce planar digital x-ray images of 

the entire breast. This generic type of 

device may include digital 

mammography acquisition software, 

full-field digital image receptor, 

acquisition workstation, automatic 

exposure control, image processing and 

reconstruction programs, patient and 

equipment supports, component parts, 

and accessories. Based on the history of 

use of this type of device since the first 

PMA was approved in 2000, FDA 

concludes that reclassification from 

class III into class II (special controls) 

would ensure safety and effectiveness of 

these devices without undue regulatory 

burden. Manufacturers must address the 

issues identified by the special controls 

guidance document. Manufacturers of 

new or modified FFDM devices would 

be subject to premarket notification 

requirements, but the burden of 

submitting a 510(k) would be 

substantially less than that of preparing 

a PMA. 

VIII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain State 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

U.S.C. 360k; See Medtronic v. Lohr 518 

U.S. 470 (1996); Riegel v. Medtronic, 

552 U.S. 312 (2008). The special 

controls established by this final rule 

create ‘‘requirements’’ to address each 

identified risk to health presented by 

these specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors may have flexibility in how 

they meet those requirements. Cf. 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–42 (9th Cir. 1997). 

IX. Paperwork Reduction Act of 1995 

This final rule establishes as special 

controls a guidance document that 

refers to previously approved 

collections of information found in FDA 

regulations. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

Elsewhere in this issue of the Federal 

Register, FDA is issuing a document 

announcing the availability of the 

guidance document that will serve as 

the special control for this device. That 

document contains an analysis of the 

paperwork burden for the guidance 

document. 

X. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Radiological Devices Panel, 

Transcript, pp. 142–156, available at 

http://www.accessdata.fda.gov/scripts/

cdrh/cfdocs/cfAdvisory/details.

cfm?mtg=659, May 23, 2006. 

2. Pisano, E., C. Gatsonis, E. Hendrick, 

et al., ‘‘Digital Mammographic Imaging 

Screening Trial (DMIST) Investigators 

Group,’’ ‘‘Diagnostic Performance of 

Digital Versus Film Mammography for 

Breast-Cancer Screening,’’ New England 

Journal of Medicine, 353: 1773–1783, 

2005. 

3. Yaffe, M., A. Bloomquist, G. 

Mawdsley, et al., ‘‘Quality Control for 

Digital Mammography: Part II 

Recommendations From the ACRIN 

DMIST Trial,’’ Medical Physics, 33(3): 

737–752, 2006. 

4. Thomas, J., K. Chakrabarti, R. 

Kaczmarek, et al., ‘‘Contrast Detail 

Phantom Scoring Methodology,’’ 

Medical Physics, 32(3), 807, 2005. 

5. Device Recalls Are Described in 

FDA’s Briefing Information, Slide 

Number 12, available at http:// 

www.fda.gov/ohrms/dockets/ac/06/

briefing/2006-4219b1_04_draft%

20FDA%20presentation.pdf, May 23, 

2006. 

List of Subjects in 21 CFR Part 892 

Medical devices, Radiation 

protection, X-rays. 

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Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations 68203 

1PBGC has an internal directive which provides 

procedures to recover debts owed to PBGC from the 

current pay account of an employee, and to process 

Continued 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 892 is 

amended as follows: 

PART 892—RADIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 892 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 892.1715 is added to 

subpart B to read as follows: 

§ 892.1715 Full-field digital mammography 

system. 

(a) Identification. A full-field digital 

mammography system is a device 

intended to produce planar digital x-ray 

images of the entire breast. This generic 

type of device may include digital 

mammography acquisition software, 

full-field digital image receptor, 

acquisition workstation, automatic 

exposure control, image processing and 

reconstruction programs, patient and 

equipment supports, component parts, 

and accessories. 

(b) Classification. Class II (special 

controls). The special control for the 

device is FDA’s guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Full-Field Digital 

Mammography System.’’ See § 892.1(e) 

for the availability of this guidance 

document. 

Dated: November 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28007 Filed 11–4–10; 8:45 am] 

BILLING CODE 4160–01–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Parts 4003 and 4903 

Debt Collection 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Pension Benefit Guaranty Corporation’s 

(PBGC) regulation on debt collection to 

conform to the Debt Collection 

Improvement Act of 1996, the Federal 

Claims Collection Standards and other 

legal requirements applicable to the 

collection of non-tax debts owed to 

PBGC. PBGC is adding salary offset and 

administrative wage garnishment to the 

collection methods allowed under the 

current regulation and making other 

changes to strengthen PBGC’s debt 

collection program. 

DATES: Effective December 6, 2010 (See 

Applicability in SUPPLEMENTARY

INFORMATION.) 

FOR FURTHER INFORMATION CONTACT: 

Margaret E. Drake, Attorney, Office of 

the General Counsel, Pension Benefit 

Guaranty Corporation, 1200 K Street, 

NW., Washington, DC 20005–4026; 202– 

326–4400 (extension 3228). (For TTY/ 

TDD users, call the Federal relay service 

toll-free at 1–800–877–8339 and ask to 

be connected to 202–326–4400 

(extension 3228)). 

SUPPLEMENTARY INFORMATION: This final 

rule revises and replaces BGC’s debt 

collection regulations found at 29 CFR 

Part 4903 to conform to the Debt 

Collection Improvement Act of 1996 

(DCIA), Public Law 104–134, 110 Stat. 

1321, 1358 (April 26, 1996), the revised 

Federal Claims Collection Standards, 31 

CFR Chapter IX (Parts 900 through 904), 

and other laws applicable to the 

collection of non-tax debt owed to the 

Government. 

Background 

In 1994, PBGC adopted a regulation 

on debt collection to provide procedures 

to implement administrative offset, as 

authorized by the Federal Claims 

Collection Act of 1966, as amended by 

the Debt Collection Act of 1982 (31 

U.S.C. 3701, et seq.), and in accordance 

with regulations issued by the 

Department of Justice and the General 

Accountability Office. In 1995, PBGC 

adopted a regulation on debt collection 

to provide procedures to implement tax 

refund offset, as required for 

participation in the Federal tax refund 

offset program authorized by 31 U.S.C. 

3720A and in accordance with 

regulations issued by the Treasury 

Department. Together, these regulations 

comprise PBGC’s current debt collection 

regulation (29 CFR part 4903) providing 

procedures for debt collection through 

administrative offset and tax refund 

offset. Administrative offset allows 

PBGC to request that debts owed to 

PBGC by a debtor (e.g., in connection 

with government contractual 

obligations) be offset by amounts 

another Federal agency may owe to the 

debtor. Likewise, other Federal agencies 

may request the collection of debts 

owed to them be offset by amounts 

PBGC may owe the debtor. Tax refund 

offset allows PBGC to request that debts 

owed to PBGC by a debtor be offset by 

amounts the Government may owe to 

the debtor. The Debt Collection 

Improvement Act of 1996 (DCIA) 

fundamentally changed the manner in 

which the Federal government is 

required to manage the collection of its 

delinquent debts. Under DCIA, Congress 

directed that the management of 

delinquent obligations is to be 

centralized at the Treasury Department 

in order to increase the efficiency of the 

Government’s collection efforts. 

Pursuant to 31 U.S.C. 3716, to utilize 

the administrative offset tools under 

DCIA, Federal agencies had to ‘‘adopt, 

without change, regulations on 

collecting by administrative offset 

promulgated by the Department of 

Justice, the Government Accountability 

Office, or the Department of the 

Treasury,’’ or promulgate their own 

regulations consistent with the 

regulations issued by the Department of 

Justice, the General Accountability 

Office, or the Department of the 

Treasury. On November 20, 2000, the 

Department of Justice and the 

Department of the Treasury revised the 

FCCS. 65 FR 70390 (Nov. 20, 2000). 

On July 22, 2010 (at 75 FR 42662), 

PBGC published a proposed rule to 

revise its regulation on debt collection 

to conform the Debt Collection 

Improvement Act of 1996, the Federal 

Claims Collections Standards, other 

legal requirements applicable to non-tax 

debts owed to PBGC, and to add salary 

offset and administrative wage 

garnishment to the collection methods 

allowed under the current regulation 

and make other changes to strengthen 

PBGC’s debt collection program. PBGC 

received no public comments on the 

proposed rule and the final regulation is 

unchanged from the proposed 

regulation. 

Overview of Final Rule 

This final regulation revises the 

procedures for the collection of non-tax 

debts owed to PBGC through 

administrative offset and tax refund 

offset. It adopts the FCCS and 

supplements it by prescribing 

procedures consistent with the FCCS, as 

necessary and appropriate for PBGC 

operations. The final regulation also 

provides for the collection of debts via 

salary offset and the use of 

administrative wage garnishment. 

Salary offset is the collection of debt 

owed by a Federal employee by 

withholding up to 15 percent of the 

employee’s disposable pay. The 

procedures for salary offset are governed 

by 5 U.S.C. 5514, and Office of 

Personnel Management (OPM) 

regulations (5 CFR part 550, subpart k). 

OPM regulations provide for salary 

offset through the Treasury Offset 

Program.1 Administrative wage 

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