This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

51869 

Vol. 76, No. 161 

Friday, August 19, 2011 

FEDERAL HOUSING FINANCE 

AGENCY 

12 CFR Part 1204 

RIN 2590–AA46 

Privacy Act Implementation 

AGENCY: Federal Housing Finance 

Agency. 

ACTION: Interim final regulation with 

request for comments. 

SUMMARY: The Federal Housing Finance 

Agency (FHFA) is issuing this interim 

final regulation with a request for 

comments on changes to its existing 

Privacy Act regulation. The changes to 

the existing Privacy Act regulation 

provide the procedures and guidelines 

under which FHFA and FHFA Office of 

Inspector General (FHFA–OIG) will 

implement the Privacy Act of 1974, as 

amended (5 U.S.C. 552a) (Privacy Act). 

The interim final regulation describes 

the policies and procedures whereby 

individuals may obtain notification of 

whether an FHFA or FHFA–OIG system 

of records contains information about 

the individual and, if so, how to access 

or amend a record under the Privacy 

Act. 

DATES: The interim final regulation is 

effective August 19, 2011. FHFA will 

accept comments on the interim final 

regulation on or before October 18, 

2011. For additional information, see 

SUPPLEMENTARY INFORMATION. 

ADDRESSES: You may submit your 

comments on the interim final 

regulation, identified by ‘‘RIN 2590– 

AA46,’’ by any one of the following 

methods: 

• E-mail: Comments to Alfred M. 

Pollard, General Counsel, may be sent 

by e-mail to RegComments@fhfa.gov. 

Please include ‘‘RIN 2590–AA46’’ in the 

subject line of the message. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. If 

you submit your comment to the 

Federal eRulemaking Portal, please also 

send it by e-mail to FHFA at 

RegComments@fhfa.gov to ensure 

timely receipt by FHFA. Include the 

following information in the subject line 

of your submission: ‘‘Comments/RIN 

2590–AA46.’’ 

• U.S. Mail Service, United Parcel 

Service, Federal Express, or other 

commercial delivery service to: Alfred 

M. Pollard, General Counsel, Attention: 

Comments/RIN 2590–AA46, Federal 

Housing Finance Agency, Fourth Floor, 

1700 G Street, NW., Washington, DC 

20552. Please note that all mail sent to 

FHFA via the U.S. Mail service is routed 

through a national irradiation facility, a 

process that may delay delivery by 

approximately two weeks. For any timesensitive correspondence, please plan 

accordingly. 

• Hand Delivery/Courier to: Alfred M. 

Pollard, General Counsel, Attention: 

Comments/RIN 2590–AA46, Federal 

Housing Finance Agency, Fourth Floor, 

1700 G Street, NW., Washington, DC 

20552. The package must be logged at 

the Guard Desk, First Floor, on business 

days between 9 a.m. and 3 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Stacy J. Easter, Privacy Act Officer, 

telephone (202) 414–3762; David A. Lee, 

Senior Agency Official for Privacy, 

telephone (202) 414–3804, (not toll-free 

numbers), Federal Housing Finance 

Agency, 1700 G Street, NW., 

Washington, DC 20552. The telephone 

number for the Telecommunications 

Device for the Deaf is (800) 877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Comments 

FHFA is issuing an amendment to 12 

CFR part 1204 to include language 

concerning Privacy Act requests as they 

relate to FHFA–OIG, as well as to clarify 

and update the existing regulation. 

FHFA invites comments on all aspects 

of the interim final regulation and will 

take all comments into consideration 

before issuing a final regulation. All 

submissions received must include the 

agency name or Regulatory Information 

Number (RIN) for this rulemaking. 

Copies of all comments received will be 

posted without change on the FHFA 

Web site, http://www.fhfa.gov, and will 

include any personal information 

provided. In addition, copies of all 

comments received will be available for 

examination by the public on business 

days between the hours of 10 a.m. and 

3 p.m. at the Federal Housing Finance 

Agency, Fourth Floor, 1700 G Street, 

NW., Washington, DC 20552. To make 

an appointment to inspect comments, 

please call the Office of General Counsel 

at (202) 414–6924. 

II. Effective Date and Request for 

Comments 

FHFA has concluded that good cause 

exists, under 5 U.S.C. 553(b)(B) and 

(d)(3), to waive the notice-and-comment 

and delayed effective date requirements 

of the Administrative Procedure Act and 

to proceed with this interim final 

regulation. The changes to part 1204 

primarily cover how FHFA–OIG will 

implement the Privacy Act and make 

clarifying and general updates to the 

existing regulation, but do not 

fundamentally change the regulation’s 

nature or scope. Further, in light of the 

significant need for immediate guidance 

regarding FHFA–OIG’s role in the 

Privacy Act process, FHFA has 

determined that notice-and-comment 

rulemaking is impracticable and 

contrary to public policy. Nevertheless, 

FHFA is providing the public with a 60- 

day period following publication of this 

document to submit comments on the 

interim final regulation. 

III. Background 

A. Establishment of the Federal Housing 

Finance Agency 

The Housing and Economic Recovery 

Act of 2008 (HERA), Public Law 110– 

289, 122 Stat. 2654, amended the 

Federal Housing Enterprises Financial 

Safety and Soundness Act of 1992 

(Safety and Soundness Act) (12 U.S.C. 

4501 et seq.) and the Federal Home 

Loan Bank Act (12 U.S.C. 1421–1449) to 

establish FHFA as an independent 

agency of the Federal Government to 

ensure that the Federal National 

Mortgage Association, the Federal Home 

Loan Mortgage Corporation, and the 

Federal Home Loan Banks (collectively, 

the regulated entities) are capitalized 

adequately; foster liquid, efficient, 

competitive and resilient national 

housing finance markets; operate in a 

safe and sound manner; comply with 

the Safety and Soundness Act and all 

rules, regulations, guidelines and orders 

issued under the Safety and Soundness 

Act, and the regulated entities’ 

respective authorizing statutes; carry out 


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their missions through activities 

consistent with the aforementioned 

authorities; and the activities and 

operations of the regulated entities are 

consistent with the public interest. 

In 2009 FHFA issued a final 

regulation on the Privacy Act at 12 CFR 

part 1204 (74 FR 33907 (July 14, 2009)). 

The final regulation provided the 

procedures and guidelines under which 

FHFA would implement the Privacy 

Act. FHFA–OIG did not exist when the 

regulation was adopted, but came into 

existence the following year (2010). This 

interim final regulation amends FHFA’s 

2009 Privacy Act regulation by adding 

provisions on how FHFA–OIG will 

implement the Privacy Act as well as to 

clarify and update the existing 

regulation. 

B. Establishment of the Office of 

Inspector General for the Federal 

Housing Finance Agency 

Section 1105 of HERA amended the 

Safety and Soundness Act and the 

Inspector General Act of 1978, as 

amended, by specifying that there shall 

be established an Inspector General 

within FHFA. See 12 U.S.C. 4517(d). 

Among other duties, FHFA–OIG is 

responsible for conducting audits, 

evaluations, and investigations of 

FHFA’s programs and operations; 

recommending polices that promote 

economy and efficiency in the 

administration of FHFA’s programs and 

operations; and preventing and 

detecting fraud, waste, and abuse in 

FHFA’s programs and operations. 

C. Privacy Act 

The Privacy Act serves to balance the 

Federal Government’s need to maintain 

information about individuals while 

protecting individuals against 

unwarranted invasions of privacy 

stemming from Federal agencies’ 

collection, maintenance, use, security, 

and disclosure of personal information 

about them that is contained in systems 

of records. The Privacy Act requires 

each Federal agency to publish 

regulations describing its Privacy Act 

procedures and any system of records it 

exempts from provisions of the Privacy 

Act, including the reasons for the 

exemption. Pursuant to the Privacy Act, 

FHFA and FHFA–OIG will inform the 

public of each system of records it 

maintains by separately publishing 

notices of each system of records in the 

Federal Register and also on the FHFA 

Web site at http://www.fhfa.gov. The 

notices will describe the standards for 

FHFA and FHFA–OIG employees 

regarding collection, use, maintenance, 

or disclosure of records in the system 

and identify whether information in the 

system is exempt from provisions of the 

Privacy Act. The system manager 

responsible for the system will also be 

identified and any other contact 

information will be included. Moreover, 

notices will provide individuals with 

detailed information regarding the 

exercise of their rights, such as how to 

determine whether a system contains a 

record pertaining to them, how to access 

those records, how to seek to amend or 

correct information in a record about 

them, and how to contest adverse 

determinations with respect to such a 

record. 

IV. Section-by-Section Analysis 

Section 1204.1 Why did FHFA issue 

this regulation? 

This section describes the purpose of 

the regulation, which is to implement 

the Privacy Act, and explains general 

policies and procedures for individuals 

requesting access to records, requesting 

amendments or corrections to records, 

and requesting an accounting of 

disclosures of records. In addition, there 

are minor editorial changes to the 

existing regulation for clarity and 

consistency purposes, as well as to 

notify the public that this regulation 

applies to FHFA–OIG. 

Section 1204.2 What do the terms in 

this regulation mean? 

This section sets forth definitions of 

select terms in this part and includes 

new definitions, as well as definitions 

relating to FHFA–OIG. 

Section 1204.3 How do I make a 

Privacy Act request? 

This section is amended to explain 

what an individual must do to submit 

a valid request to FHFA or FHFA–OIG 

for access to records, to amend or 

correct records, or for an accounting of 

disclosures of records. It also describes 

the information an individual must 

provide to FHFA or FHFA–OIG so that 

FHFA or FHFA–OIG may identify the 

records sought and determine whether 

the request can be granted. 

Section 1204.4 How will FHFA or 

FHFA–OIG respond to my Privacy Act 

request? 

This section describes the period of 

time within which FHFA or FHFA–OIG 

will respond to requests. It also explains 

that FHFA or FHFA–OIG will grant or 

deny requests in writing, provide 

reasons if a request is denied in whole 

or in part, and explain the right of 

appeal. In addition, there are minor 

editorial changes to the existing 

regulation for clarity and consistency 

purposes. 

Section 1204.5 What if I am 

dissatisfied with the response to my 

Privacy Act request? 

This section describes when and how 

an individual may appeal an FHFA or 

FHFA–OIG determination on a Privacy 

Act request and how and within what 

period of time FHFA or FHFA–OIG will 

make a determination on an appeal. In 

addition, minor editorial changes have 

been made for clarity and consistency 

purposes. 

Section 1204.6 What does it cost to get 

records under the Privacy Act? 

This section explains that requesters 

are expected to pay fees for the 

duplication of requested records. 

Section 1204.7 Are there any 

exemptions from the Privacy Act? 

This section explains that certain 

exemptions from the Privacy Act exist, 

explains how those exemptions are 

made effective, what the effect of an 

exemption is, and how to determine 

whether an exemption applies. In 

particular, this section details those 

FHFA–OIG records that are potentially 

exempt from the Privacy Act. In 

addition, minor editorial changes have 

been made for clarity and consistency 

purposes. 

Section 1204.8 How are records 

secured? 

This section explains how FHFA and 

FHFA–OIG generally protect records 

under the Privacy Act. 

Section 1204.9 Does FHFA or FHFA– 

OIG collect and use Social Security 

numbers? 

This section explains that FHFA and 

FHFA–OIG collect Social Security 

numbers only when authorized and 

describes the conditions under which 

they may be collected. 

Section 1204.10 What are FHFA and 

FHFA–OIG employee responsibilities 

under the Privacy Act? 

This section lists the responsibilities 

of FHFA employees under the Privacy 

Act. 

Section 1204.11 May FHFA–OIG 

obtain Privacy Act records from other 

federal agencies for law enforcement 

purposes? 

This is a new section. This section 

explains that the FHFA Inspector 

General or designee may obtain records 

under the Privacy Act from other 

Federal agencies for law enforcement 

purposes. 


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Regulatory Impacts 

Paperwork Reduction Act 

The interim final regulation does not 

contain any information collection 

requirement that requires the approval 

of OMB under the Paperwork Reduction 

Act (44 U.S.C. 3501 et seq.). 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) requires that a 

regulation that has a significant 

economic impact on a substantial 

number of small entities, small 

businesses, or small organizations 

include an initial regulatory flexibility 

analysis describing the regulation’s 

impact on small entities. Such an 

analysis need not be undertaken if the 

agency has certified that the regulation 

does not have a significant economic 

impact on a substantial number of small 

entities. 5 U.S.C. 605(b). FHFA has 

considered the impact of the interim 

final regulation under the Regulatory 

Flexibility Act. FHFA certifies that the 

regulation is not likely to have a 

significant economic impact on a 

substantial number of small business 

entities because the regulation is 

applicable to the internal operations and 

legal obligations of FHFA and FHFA– 

OIG. 

List of Subjects in 12 CFR Part 1204 

Amendment, Appeals, Correction, 

Disclosure, Exemptions, Fees, Privacy, 

Privacy Act, Records, Requests, Social 

Security numbers. 

Authority and Issuance 

Accordingly, for the reasons stated in 

the preamble, FHFA revises part 1204 of 

chapter XII of title 12 of the Code of 

Federal Regulations to read as follows: 

PART 1204—PRIVACY ACT 

IMPLEMENTATION 

Sec. 

1204.1 Why did FHFA issue this part? 

1204.2 What do the terms in this part 

mean? 

1204.3 How do I make a Privacy Act 

request? 

1204.4 How will FHFA or FHFA–OIG 

respond to my Privacy Act request? 

1204.5 What if I am dissatisfied with the 

response to my Privacy Act request? 

1204.6 What does it cost to get records 

under the Privacy Act? 

1204.7 Are there any exemptions from the 

Privacy Act? 

1204.8 How are records secured? 

1204.9 Does FHFA or FHFA–OIG collect 

and use Social Security numbers? 

1204.10 What are FHFA and FHFA–OIG 

employee responsibilities under the 

Privacy Act? 

1204.11 May FHFA–OIG obtain Privacy Act 

records from other Federal agencies for 

law enforcement purposes? 

Authority: 5 U.S.C. 552a. 

§ 1204.1 Why did FHFA issue this part? 

The Federal Housing Finance Agency 

(FHFA) issued this part to— 

(a) Implement the Privacy Act, a 

Federal law that helps protect private 

information about individuals that 

Federal agencies collect or maintain. 

You should read this part together with 

the Privacy Act, which provides 

additional information about records 

maintained on individuals; 

(b) Establish rules that apply to all 

FHFA and FHFA Office of Inspector 

General (FHFA–OIG) maintained 

systems of records retrievable by an 

individual’s name or other personal 

identifier; 

(c) Describe procedures through 

which you may request access to 

records, request amendment or 

correction of those records, or request 

an accounting of disclosures of those 

records by FHFA or FHFA–OIG; 

(d) Inform you, that when it is 

appropriate to do so, FHFA or FHFA– 

OIG automatically processes a Privacy 

Act request for access to records under 

both the Privacy Act and FOIA, 

following the rules contained in this 

part and in FHFA’s Freedom of 

Information Act regulation at part 1202 

of this title so that you will receive the 

maximum amount of information 

available to you by law; 

(e) Notify you that this part does not 

entitle you to any service or to the 

disclosure of any record to which you 

are not entitled under the Privacy Act. 

It also does not, and may not be relied 

upon, to create any substantive or 

procedural right or benefit enforceable 

against FHFA or FHFA–OIG; and 

(f) Notify you that this part applies to 

both FHFA and FHFA–OIG. 

§ 1204.2 What do the terms in this part 

mean? 

The following definitions apply to the 

terms used in this part— 

Access means making a record 

available to a subject individual. 

Amendment means any correction of, 

addition to, or deletion from a record. 

Court means any entity conducting a 

legal proceeding. 

Days, unless stated as ‘‘calendar 

days,’’ are working days and do not 

include Saturdays, Sundays, and federal 

holidays. If the last day of any period 

prescribed herein falls on a Saturday, 

Sunday, or federal holiday, the last day 

of the period will be the next working 

day that is not a Saturday, Sunday, or 

federal holiday. 

FHFA means the Federal Housing 

Finance Agency and includes its 

predecessor agencies, the Office of 

Federal Housing Enterprise Oversight 

(OFHEO) and the Federal Housing 

Finance Board (FHFB). 

FHFA–OIG means the Office of 

Inspector General for FHFA. 

FOIA means the Freedom of 

Information Act, as amended (5 U.S.C. 

552). 

Individual means a natural person 

who is either a citizen of the United 

States of America or an alien lawfully 

admitted for permanent residence. 

Maintain includes collect, use, 

disseminate, or control. 

Privacy Act means the Privacy Act of 

1974, as amended (5 U.S.C. 552a). 

Privacy Act Appeals Officer means a 

person designated by the FHFA Director 

to process appeals of denials of requests 

for or seeking amendment of records 

maintained by FHFA under the Privacy 

Act. For appeals pertaining to records 

maintained by FHFA–OIG, Privacy Act 

Appeals Officer means a person 

designated by the FHFA Inspector 

General to process appeals of denials of 

requests for or seeking amendment of 

records maintained by FHFA–OIG 

under the Privacy Act. 

Privacy Act Officer means a person 

designated by the FHFA Director who 

has primary responsibility for privacy 

and data protection policy and is 

authorized to process requests for or 

amendment of records maintained by 

FHFA under the Privacy Act. For 

requests pertaining to records 

maintained by FHFA–OIG, Privacy Act 

Officer means a person designated by 

the FHFA Inspector General to process 

requests for or amendment of records 

maintained by FHFA–OIG under the 

Privacy Act. 

Record means any item, collection, or 

grouping of information about an 

individual that FHFA or FHFA–OIG 

maintains within a system of records, 

including, but not limited to, the 

individual’s name, an identifying 

number, symbol, or other identifying 

particular assigned to the individual, 

such as a finger or voice print, or 

photograph. 

Routine use means the purposes for 

which records and information 

contained in a system of records may be 

disclosed by FHFA or FHFA–OIG 

without the consent of the subject of the 

record. Routine uses for records are 

identified in each system of records 

notice. Routine use does not include 

disclosure that subsection (b) of the 

Privacy Act (5 U.S.C. 552a(b)) otherwise 

permits. 

Senior Agency Official for Privacy 

means a person designated by the FHFA 


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Director who has the authority and 

responsibility to oversee and supervise 

the FHFA privacy program and 

implementation of the Privacy Act. 

System of Records means a group of 

records FHFA or FHFA–OIG maintains 

or controls from which information is 

retrieved by the name of an individual 

or by some identifying number, symbol, 

or other identifying particular assigned 

to the individual. Single records or 

groups of records that are not retrieved 

by a personal identifier are not part of 

a system of records. 

System of Records Notice means a 

notice published in the Federal Register 

which announces the creation, deletion, 

or amendment of one or more system of 

records. System of records notices are 

also used to identify a system of records’ 

routine uses. 

§ 1204.3 How do I make a Privacy Act 

request? 

(a) What is a valid request? In general, 

a Privacy Act request can be made on 

your own behalf for records or 

information about you. You can make a 

Privacy Act request on behalf of another 

individual as the parent or guardian of 

a minor, or as the guardian of someone 

determined by a court to be 

incompetent. You also may request 

access to another individual’s record or 

information if you have that 

individual’s written consent, unless 

other conditions of disclosure apply. 

(b) How and where do I make a 

request? Your request must be in 

writing. Regardless of whether your 

request seeks records from FHFA, 

FHFA–OIG, or both, you may appear in 

person to submit your written request to 

the FHFA Privacy Act Officer, or send 

your written request to the FHFA 

Privacy Act Officer by electronic mail, 

mail, delivery service, or facsimile. The 

electronic mail address is: 

privacy@fhfa.gov. For mail or delivery 

service, the address is: FHFA Privacy 

Act Officer, Federal Housing Finance 

Agency, 1700 G Street, NW., 

Washington, DC 20552. The facsimile 

number is (202) 414–6425. Requests for 

FHFA–OIG maintained records will be 

forwarded to FHFA–OIG for processing 

and direct response. You can help 

FHFA and FHFA–OIG process your 

request by marking electronic mail, 

letters, or facsimiles and the subject 

line, envelope, or facsimile cover sheet 

with ‘‘Privacy Act Request.’’ FHFA’s 

‘‘Privacy Act Reference Guide,’’ which 

is available on FHFA’s Web site, 

http://www.fhfa.gov, provides 

additional information to assist you in 

making your request. 

(c) What must the request include? 

You must describe the record that you 

want in enough detail to enable either 

the FHFA or FHFA–OIG Privacy Act 

Officer to locate the system of records 

containing it with a reasonable amount 

of effort. Include specific information 

about each record sought, such as the 

time period in which you believe it was 

compiled, the name or identifying 

number of each system of records in 

which you believe it is kept, and the 

date, title or name, author, recipient, or 

subject matter of the record. As a 

general rule, the more specific you are 

about the record that you want, the 

more likely FHFA or FHFA–OIG will be 

able to locate it in response to your 

request. 

(d) How do I request amendment or 

correction of a record? If you are 

requesting an amendment or correction 

of any FHFA or FHFA–OIG record, 

identify each particular record in 

question and the system of records in 

which the record is located, describe the 

amendment or correction that you want, 

and state why you believe that the 

record is not accurate, relevant, timely, 

or complete. You may submit any 

documentation that you think would be 

helpful, including an annotated copy of 

the record. 

(e) How do I request for an accounting 

of disclosures? If you are requesting an 

accounting of disclosures by FHFA or 

FHFA–OIG of a record to another 

person, organization, or Federal agency, 

you must identify each particular record 

in question. An accounting generally 

includes the date, nature, and purpose 

of each disclosure, as well as the name 

and address of the person, organization, 

or Federal agency to which the 

disclosure was made, subject to 

§ 1204.7. 

(f) Must I verify my identity? Yes. 

When making requests under the 

Privacy Act, your request must verify 

your identity to protect your privacy or 

the privacy of the individual on whose 

behalf you are acting. If you make a 

Privacy Act request and you do not 

follow these identity verification 

procedures, FHFA or FHFA–OIG cannot 

and will not process your request. 

(1) How do I verify my identity? To 

verify your identity, you must state your 

full name, current address, and date and 

place of birth. In order to help identify 

and locate the records you request, you 

also may, at your option, include your 

Social Security number. If you make 

your request in person and your identity 

is not known to either the FHFA or 

FHFA–OIG Privacy Act Officer, you 

must provide either two forms of 

unexpired identification with 

photographs issued by a federal, state, 

or local government agency or entity 

(i.e. passport, passport card, driver’s 

license, ID card, etc.), or one form of 

unexpired identification with a 

photograph issued by a federal, state, or 

local government agency or entity (i.e. 

passport, passport card, driver’s license, 

ID card, etc.) and a properly 

authenticated birth certificate. If you 

make your request by mail, your 

signature either must be notarized or 

submitted under 28 U.S.C. 1746, a law 

that permits statements to be made 

under penalty of perjury as a substitute 

for notarization. You may fulfill this 

requirement by having your signature 

on your request letter witnessed by a 

notary or by including the following 

statement just before the signature on 

your request letter: ‘‘I declare (or certify, 

verify, or state) under penalty of perjury 

that the foregoing is true and correct. 

Executed on [date]. [Signature].’’ 

(2) How do I verify parentage or 

guardianship? If you make a Privacy Act 

request as the parent or guardian of a 

minor, or as the guardian of someone 

determined by a court to be 

incompetent, with respect to records or 

information about that individual, you 

must establish— 

(i) The identity of the individual who 

is the subject of the record, by stating 

the individual’s name, current address, 

date and place of birth, and, at your 

option, the Social Security number of 

the individual; 

(ii) Your own identity, as required in 

paragraph (f)(1) of this section; 

(iii) That you are the parent or 

guardian of the individual, which you 

may prove by providing a properly 

authenticated copy of the individual’s 

birth certificate showing your parentage 

or a properly authenticated court order 

establishing your guardianship; and 

(iv) That you are acting on behalf of 

the individual in making the request. 

§ 1204.4 How will FHFA or FHFA–OIG 

respond to my Privacy Act request? 

(a) How will FHFA or FHFA–OIG 

locate the requested records? FHFA or 

FHFA–OIG will search to determine if 

requested records exist in the system of 

records it owns or controls. You can 

find FHFA and FHFA–OIG system of 

records notices on our Web site at 

http://www.fhfa.gov. You can also find 

descriptions of OFHEO and FHFB 

system of records that have not yet been 

superseded on the FHFA Web site. A 

description of the system of records also 

is available in the ‘‘Privacy Act 

Issuances’’ compilation published by 

the Office of the Federal Register of the 

National Archives and Records 

Administration. You can access the 

‘‘Privacy Act Issuances’’ compilation in 

most large reference and university 

libraries or electronically at the 


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Government Printing Office Web site at: 

http://www.gpoaccess.gov/privacyact/ 

index.html. You also can request a copy 

of FHFA or FHFA–OIG system of 

records from the Privacy Act Officer. 

(b) How long does FHFA or FHFA– 

OIG have to respond? Either the FHFA 

or FHFA–OIG Privacy Act Officer 

generally will respond to your request 

in writing within 20 days after receiving 

it, if it meets the § 1204.3 requirements. 

For requests to amend a record, either 

the FHFA or FHFA–OIG Privacy Act 

Officer will respond within 10 days 

after receipt of the request to amend. 

FHFA or FHFA–OIG may extend the 

response time in unusual 

circumstances, such as when 

consultation is needed with another 

Federal agency (if that agency is subject 

to the Privacy Act) about a record or to 

retrieve a record shipped offsite for 

storage. If you submit your written 

request in person, either the FHFA or 

FHFA–OIG Privacy Act Officer may 

disclose records or information to you 

directly and create a written record of 

the grant of the request. If you are to be 

accompanied by another person when 

accessing your record or any 

information pertaining to you, FHFA or 

FHFA–OIG may require your written 

authorization before permitting access 

or discussing the record in the presence 

of the other person. 

(c) What will the FHFA or FHFA–OIG 

response include? The written response 

will include a determination to grant or 

deny your request in whole or in part, 

a brief explanation of the reasons for the 

determination, and the amount of the 

fee charged, if any, under § 1204.6. If 

you are granted a request to access a 

record, FHFA or FHFA–OIG will make 

the record available to you. If you are 

granted a request to amend or correct a 

record, the response will describe any 

amendments or corrections made and 

advise you of your right to obtain a copy 

of the amended or corrected record. 

(d) What is an adverse determination? 

An adverse determination is a 

determination on a Privacy Act request 

that— 

(1) Withholds any requested record in 

whole or in part; 

(2) Denies a request for an amendment 

or correction of a record in whole or in 

part; 

(3) Declines to provide a requested 

accounting of disclosures; 

(4) Advises that a requested record 

does not exist or cannot be located; or 

(5) Finds what has been requested is 

not a record subject to the Privacy Act. 

(e) What will be stated in a response 

that includes an adverse determination? 

If an adverse determination is made 

with respect to your request, either the 

FHFA or FHFA–OIG Privacy Act 

Officer’s written response under this 

section will identify the person 

responsible for the adverse 

determination, state that the adverse 

determination is not a final action of 

FHFA or FHFA–OIG, and state that you 

may appeal the adverse determination 

under § 1204.5. 

§ 1204.5 What if I am dissatisfied with the 

response to my Privacy Act request? 

(a) May I appeal the response? You 

may appeal any adverse determination 

made in response to your Privacy Act 

request. If you wish to seek review by 

a court of any adverse determination or 

denial of a request, you must first 

appeal it under this section. 

(b) How do I appeal the response?— 

(1) You may appeal by submitting in 

writing, a statement of the reasons you 

believe the adverse determination 

should be overturned. FHFA or FHFA– 

OIG must receive your written appeal 

within 30 calendar days of the date of 

the adverse determination under 

§ 1204.4. Your written appeal may 

include as much or as little related 

information as you wish, as long as it 

clearly identifies the determination 

(including the request number, if 

known) that you are appealing. 

(2) If FHFA or FHFA–OIG denied 

your request in whole or in part, you 

may appeal the denial by writing 

directly to the FHFA Privacy Act 

Appeals Officer through electronic mail, 

mail, delivery service, or facsimile. The 

electronic mail address is: 

privacy@fhfa.gov. For mail or express 

mail, the address is: FHFA Privacy Act 

Appeals Officer, Federal Housing 

Finance Agency, 1700 G Street, NW., 

Washington, DC 20552. The facsimile 

number is: (202) 414–8917. For appeals 

of FHFA–OIG denials, whether in whole 

or in part, the appeal must be clearly 

marked by adding ‘‘FHFA–OIG’’ after 

‘‘Privacy Act Appeal.’’ All appeals from 

denials, in whole or part, made by 

FHFA–OIG will be forwarded to the 

FHFA–OIG Privacy Act Appeals Officer 

for processing and direct response. You 

can help FHFA and FHFA–OIG process 

your appeal by marking electronic mail, 

letters, or facsimiles and the subject 

line, envelope, or facsimile cover sheet 

with ‘‘Privacy Act Appeal.’’ FHFA’s 

‘‘Privacy Act Reference Guide,’’ which 

is available on FHFA’s Web site, 

http://www.fhfa.gov, provides 

additional information to assist you in 

making your appeal. FHFA or FHFA– 

OIG ordinarily will not act on an appeal 

if the Privacy Act request becomes a 

matter of litigation. 

(3) If you need more time to file your 

appeal, you may request an extension of 

time of no more than ten (10) calendar 

days in which to file your appeal, but 

only if your request is made within the 

original 30-calendar day time period for 

filing the appeal. Granting an extension 

is in the sole discretion of either the 

FHFA or FHFA–OIG Privacy Act 

Appeals Officer. 

(c) Who has the authority to grant or 

deny appeals? For appeals from the 

FHFA Privacy Act Officer, the FHFA 

Privacy Act Appeals Officer is 

authorized to act on your appeal. For 

appeals from the FHFA–OIG Privacy 

Act Officer, the FHFA–OIG Privacy Act 

Appeals Officer is authorized to act on 

your appeal. 

(d) When will FHFA or FHFA–OIG 

respond to my appeal? FHFA or FHFA– 

OIG generally will respond to you in 

writing within 30 days of receipt of an 

appeal that meets the requirements of 

paragraph (b) of this section, unless for 

good cause shown, the FHFA or FHFA– 

OIG Privacy Act Appeals Officer 

extends the response time. 

(e) What will the FHFA or FHFA–OIG 

response include? The written response 

will include the determination of either 

the FHFA or FHFA–OIG Privacy Act 

Appeals Officer, whether to grant or 

deny your appeal in whole or in part, a 

brief explanation of the reasons for the 

determination, and information about 

the Privacy Act provisions for court 

review of the determination. 

(1) If your appeal concerns a request 

for access to records or information and 

the appeal determination grants your 

access, the records or information, if 

any, will be made available to you. 

(2)(i) If your appeal concerns an 

amendment or correction of a record 

and the appeal determination grants 

your request for an amendment or 

correction, the response will describe 

any amendment or correction made to 

the record and advise you of your right 

to obtain a copy of the amended or 

corrected record under this part. FHFA 

or FHFA–OIG will notify all persons, 

organizations, or Federal agencies to 

which it previously disclosed the 

record, if an accounting of that 

disclosure was made, that the record has 

been amended or corrected. Whenever 

the record is subsequently disclosed, the 

record will be disclosed as amended or 

corrected. 

(ii) If the response to your appeal 

denies your request for an amendment 

or correction to a record, the response 

will advise you of your right to file a 

Statement of Disagreement under 

paragraph (f) of this section. 

(f) What is a Statement of 

Disagreement?—(1) A Statement of 

Disagreement is a concise written 

statement in which you clearly identify 


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each part of any record that you dispute 

and explain your reason(s) for 

disagreeing with either the FHFA or 

FHFA–OIG Privacy Act Appeals 

Officer’s denial, in whole or in part, of 

your appeal requesting amendment or 

correction. Your Statement of 

Disagreement must be received by either 

the FHFA or FHFA–OIG Privacy Act 

Officer within 30 calendar days of either 

the FHFA or FHFA–OIG Privacy Act 

Appeals Officer’s denial, in whole or in 

part, of your appeal concerning 

amendment or correction of a record. 

FHFA and FHFA–OIG will place your 

Statement of Disagreement in the system 

of records in which the disputed record 

is maintained. FHFA and FHFA–OIG 

may also append a concise statement of 

its reason(s) for denying the request for 

an amendment or correction of the 

record. 

(2) FHFA and FHFA–OIG will notify 

all persons, organizations, and Federal 

agencies to which it previously 

disclosed the disputed record, if an 

accounting of that disclosure was made, 

that the record is disputed and provide 

your Statement of Disagreement and the 

FHFA or FHFA–OIG concise statement, 

if any. Whenever the disputed record is 

subsequently disclosed, a copy of your 

Statement of Disagreement and the 

FHFA or FHFA–OIG concise statement, 

if any, will also be disclosed. 

§ 1204.6 What does it cost to get records 

under the Privacy Act? 

(a) Must I agree to pay fees? Your 

Privacy Act request is your agreement to 

pay all applicable fees, unless you 

specify a limit on the amount of fees 

you agree to pay. FHFA or FHFA–OIG 

will not exceed the specified limit 

without your written agreement. 

(b) How does FHFA or FHFA–OIG 

calculate fees? FHFA and FHFA–OIG 

will charge a fee for duplication of a 

record under the Privacy Act in the 

same way it charges for duplication of 

records under FOIA in 12 CFR 1202.11. 

There are no fees to search for or review 

records. 

§ 1204.7 Are there any exemptions from 

the Privacy Act? 

(a) What is a Privacy Act exemption? 

The Privacy Act authorizes the Director 

and the FHFA Inspector General to 

exempt records or information in a 

system of records from some of the 

Privacy Act requirements, if the Director 

or the FHFA Inspector General, as 

appropriate, determines that the 

exemption is necessary. 

(b) How do I know if the records or 

information I want are exempt?—(1) 

Each system of records notice will 

advise you if the Director or the FHFA 

Inspector General has determined 

records or information in records are 

exempt from Privacy Act requirements. 

If the Director or the FHFA Inspector 

General has claimed an exemption for a 

system of records, the system of records 

notice will identify the exemption and 

the provisions of the Privacy Act from 

which the system is exempt. 

(2) Until superseded by FHFA or 

FHFA–OIG systems of records, the 

following OFHEO and FHFB systems of 

records are, under 5 U.S.C. 552a(k)(2) or 

(k)(5), exempt from the Privacy Act 

requirements of 5 U.S.C. 552a(c)(3), (d), 

(e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I), and 

(f)— 

(i) OFHEO–11 Litigation and 

Enforcement Information System; and 

(ii) FHFB–5 Agency Personnel 

Investigative Records. 

(c) What exemptions potentially apply 

to FHFA–OIG records? Unless the FHFA 

Inspector General, his or her designee, 

or a statute specifically authorizes 

disclosure, FHFA–OIG will not release 

records of matters that are subject to the 

following exemptions— 

(1) To the extent that the systems of 

records entitled ‘‘FHFA–OIG Audit Files 

Database,’’ ‘‘FHFA–OIG Investigative & 

Evaluative Files Database,’’ ‘‘FHFA–OIG 

Investigative & Evaluative MIS 

Database,’’ ‘‘FHFA–OIG Hotline 

Database,’’ and ‘‘FHFA–OIG 

Correspondence Database’’ contain any 

information compiled by FHFA–OIG for 

the purpose of criminal law 

enforcement investigations, such 

information falls within the scope of 

exemption (j)(2) of the Privacy Act, 5 

U.S.C. 552a(j)(2), and therefore these 

systems of records are exempt from the 

requirements of the following 

subsections of the Privacy Act to that 

extent, for the reasons stated in 

paragraphs (1)(i) through (vi) of this 

section. 

(i) From 5 U.S.C. 552a(c)(3), because 

release of an accounting of disclosures 

to an individual who is the subject of an 

investigation or evaluation could reveal 

the nature and scope of the investigation 

or evaluation and could result in the 

altering or destruction of evidence, 

improper influencing of witnesses, and 

other evasive actions that could impede 

or compromise the investigation or 

evaluation. 

(ii) From 5 U.S.C. 552a(d)(1), because 

release of investigative or evaluative 

records to an individual who is the 

subject of an investigation or evaluation 

could interfere with pending or 

prospective law enforcement 

proceedings, constitute an unwarranted 

invasion of the personal privacy of third 

parties, reveal the identity of 

confidential sources, or reveal sensitive 

investigative or evaluative techniques 

and procedures. 

(iii) From 5 U.S.C. 552a(d)(2), because 

amendment or correction of 

investigative or evaluative records could 

interfere with pending or prospective 

law enforcement proceedings, or could 

impose an impossible administrative 

and investigative or evaluative burden 

by requiring FHFA–OIG to continuously 

retrograde its investigations or 

evaluations attempting to resolve 

questions of accuracy, relevance, 

timeliness, and completeness. 

(iv) From 5 U.S.C. 552a(e)(1), because 

it is often impossible to determine 

relevance or necessity of information in 

the early stages of an investigation or 

evaluation. The value of such 

information is a question of judgment 

and timing; what appears relevant and 

necessary when collected may 

ultimately be evaluated and viewed as 

irrelevant and unnecessary to an 

investigation or evaluation. In addition, 

FHFA–OIG may obtain information 

concerning the violation of laws other 

than those within the scope of its 

jurisdiction. In the interest of effective 

law enforcement, FHFA–OIG should 

retain this information because it may 

aid in establishing patterns of unlawful 

activity and provide leads for other law 

enforcement agencies. Further, in 

obtaining evidence during an 

investigation or evaluation, information 

may be provided to FHFA–OIG that 

relates to matters incidental to the main 

purpose of the investigation or 

evaluation, but which may be pertinent 

to the investigative or evaluative 

jurisdiction of another agency. Such 

information cannot readily be 

identified. 

(v) From 5 U.S.C. 552a(e)(2), because 

in a law enforcement investigation or an 

evaluation it is usually 

counterproductive to collect 

information to the greatest extent 

practicable directly from the subject 

thereof. It is not always feasible to rely 

upon the subject of an investigation or 

evaluation as a source for information 

which may implicate him or her in 

illegal activities. In addition, collecting 

information directly from the subject 

could seriously compromise an 

investigation or evaluation by 

prematurely revealing its nature and 

scope, or could provide the subject with 

an opportunity to conceal criminal 

activities, or intimidate potential 

sources, in order to avoid apprehension. 

(vi) From 5 U.S.C. 552a(e)(3), because 

providing such notice to the subject of 

an investigation or evaluation, or to 

other individual sources, could 

seriously compromise the investigation 

or evaluation by prematurely revealing 


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its nature and scope, or could inhibit 

cooperation, permit the subject to evade 

apprehension, or cause interference 

with undercover activities. 

(2) To the extent that the systems of 

records entitled ‘‘FHFA–OIG Audit Files 

Database,’’ ‘‘FHFA–OIG Investigative & 

Evaluative Files Database,’’ ‘‘FHFA–OIG 

Investigative & Evaluative MIS 

Database,’’ ‘‘FHFA–OIG Hotline 

Database,’’ and ‘‘FHFA–OIG 

Correspondence Database,’’ contain 

information compiled by FHFA–OIG for 

the purpose of criminal law 

enforcement investigations, such 

information falls within the scope of 

exemption (k)(2) of the Privacy Act, 5 

U.S.C. 552a(k)(2), and therefore these 

systems of records are exempt from the 

requirements of the following 

subsections of the Privacy Act to that 

extent, for the reasons stated in 

paragraphs (c)(2)(i) through (iv) of this 

section. 

(i) From 5 U.S.C. 552a(c)(3), because 

release of an accounting of disclosures 

to an individual who is the subject of an 

investigation or evaluation could reveal 

the nature and scope of the investigation 

or evaluation and could result in the 

altering or destruction of evidence, 

improper influencing of witnesses, and 

other evasive actions that could impede 

or compromise the investigation or 

evaluation. 

(ii) From 5 U.S.C. 552a(d)(1), because 

release of investigative or evaluative 

records to an individual who is the 

subject of an investigation or evaluation 

could interfere with pending or 

prospective law enforcement 

proceedings, constitute an unwarranted 

invasion of the personal privacy of third 

parties, reveal the identity of 

confidential sources, or reveal sensitive 

investigative or evaluative techniques 

and procedures. 

(iii) From 5 U.S.C. 552a(d)(2), because 

amendment or correction of 

investigative or evaluative records could 

interfere with pending or prospective 

law enforcement proceedings, or could 

impose an impossible administrative 

and investigative or evaluative burden 

by requiring FHFA–OIG to continuously 

retrograde its investigations or 

evaluations attempting to resolve 

questions of accuracy, relevance, 

timeliness, and completeness. 

(iv) From 5 U.S.C. 552a(e)(1), because 

it is often impossible to determine 

relevance or necessity of information in 

the early stages of an investigation or 

evaluation. The value of such 

information is a question of judgment 

and timing; what appears relevant and 

necessary when collected may 

ultimately be evaluated and viewed as 

irrelevant and unnecessary to an 

investigation or evaluation. In addition, 

FHFA–OIG may obtain information 

concerning the violation of laws other 

than those within the scope of its 

jurisdiction. In the interest of effective 

law enforcement, FHFA–OIG should 

retain this information because it may 

aid in establishing patterns of unlawful 

activity and provide leads for other law 

enforcement agencies. Further, in 

obtaining evidence during an 

investigation or evaluation, information 

may be provided to FHFA–OIG that 

relates to matters incidental to the main 

purpose of the investigation or 

evaluation but which may be pertinent 

to the investigative or evaluative 

jurisdiction of another agency. Such 

information cannot readily be 

identified. 

(3) To the extent that the systems of 

records entitled ‘‘FHFA–OIG Audit Files 

Database,’’ ‘‘FHFA–OIG Investigative & 

Evaluative Files Database,’’ ‘‘FHFA–OIG 

Investigative & Evaluative MIS 

Database,’’ ‘‘FHFA–OIG Hotline 

Database,’’ and ‘‘FHFA–OIG 

Correspondence Database’’ contain any 

investigatory material compiled by 

FHFA–OIG for the purpose of 

determining suitability, eligibility, or 

qualifications for Federal civilian 

employment or Federal contracts, the 

release of which would reveal the 

identity of a source who furnished 

information to the Government under an 

express promise that the identity of the 

source would be held in confidence, 

such information falls within the scope 

of exemption (k)(5) of the Privacy Act, 

5 U.S.C. 552a(k)(5), and therefore these 

systems of records are exempt from the 

requirements of subsection (d)(1) of the 

Privacy Act to that extent, because 

release would reveal the identity of a 

source who furnished information to the 

Government under an express promise 

of confidentiality. Revealing the identity 

of a confidential source could impede 

future cooperation by sources, and 

could result in harassment or harm to 

such sources. 

§ 1204.8 How are records secured? 

(a) What controls must FHFA and 

FHFA–OIG have in place? FHFA and 

FHFA–OIG must establish 

administrative and physical controls to 

prevent unauthorized access to their 

systems of records, unauthorized or 

inadvertent disclosure of records, and 

physical damage to or destruction of 

records. The stringency of these controls 

corresponds to the sensitivity of the 

records that the controls protect. At a 

minimum, the administrative and 

physical controls must ensure that— 

(1) Records are protected from public 

view; 

(2) The area in which records are kept 

is supervised during business hours to 

prevent unauthorized persons from 

having access to them; 

(3) Records are inaccessible to 

unauthorized persons outside of 

business hours; and 

(4) Records are not disclosed to 

unauthorized persons or under 

unauthorized circumstances in either 

oral or written form. 

(b) Is access to records restricted? 

Access to records is restricted to 

authorized employees who require 

access in order to perform their official 

duties. 

§ 1204.9 Does FHFA or FHFA–OIG collect 

and use Social Security numbers? 

FHFA and FHFA–OIG collect Social 

Security numbers only when it is 

necessary and authorized. At least 

annually, the FHFA Privacy Act Officer 

or the Senior Agency Official for Privacy 

will inform employees who are 

authorized to collect information that— 

(a) Individuals may not be denied any 

right, benefit, or privilege as a result of 

refusing to provide their Social Security 

numbers, unless the collection is 

authorized either by a statute or by a 

regulation issued prior to 1975; and 

(b) They must inform individuals who 

are asked to provide their Social 

Security numbers— 

(1) If providing a Social Security 

number is mandatory or voluntary; 

(2) If any statutory or regulatory 

authority authorizes collection of a 

Social Security number; and 

(3) The uses that will be made of the 

Social Security number. 

§ 1204.10 What are FHFA and FHFA–OIG 

employee responsibilities under the Privacy 

Act? 

At least annually, the FHFA Privacy 

Act Officer or the Senior Agency 

Official for Privacy will inform 

employees about the provisions of the 

Privacy Act, including the Privacy Act’s 

civil liability and criminal penalty 

provisions. Unless otherwise permitted 

by law, an authorized FHFA or FHFA– 

OIG employee shall— 

(a) Collect from individuals only 

information that is relevant and 

necessary to discharge FHFA or FHFA– 

OIG responsibilities; 

(b) Collect information about an 

individual directly from that individual 

whenever practicable; 

(c) Inform each individual from whom 

information is collected of— 

(1) The legal authority to collect the 

information and whether providing it is 

mandatory or voluntary; 

(2) The principal purpose for which 

FHFA or FHFA–OIG intends to use the 

information; 


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(3) The routine uses FHFA or FHFA– 

OIG may make of the information; and 

(4) The effects on the individual, if 

any, of not providing the information. 

(d) Ensure that the employee’s office 

does not maintain a system of records 

without public notice and notify 

appropriate officials of the existence or 

development of any system of records 

that is not the subject of a current or 

planned public notice; 

(e) Maintain all records that are used 

in making any determination about an 

individual with such accuracy, 

relevance, timeliness, and completeness 

as is reasonably necessary to ensure 

fairness to the individual in the 

determination; 

(f) Except for disclosures made under 

FOIA, make reasonable efforts, prior to 

disseminating any record about an 

individual, to ensure that the record is 

accurate, relevant, timely, and complete; 

(g) When required by the Privacy Act, 

maintain an accounting in the specified 

form of all disclosures of records by 

FHFA or FHFA–OIG to persons, 

organizations, or Federal agencies; 

(h) Maintain and use records with 

care to prevent the unauthorized or 

inadvertent disclosure of a record to 

anyone; and 

(i) Notify the appropriate official of 

any record that contains information 

that the Privacy Act does not permit 

FHFA or FHFA–OIG to maintain. 

§ 1204.11 May FHFA–OIG obtain Privacy 

Act records from other Federal agencies for 

law enforcement purposes? 

(a) The FHFA Inspector General is 

authorized under the Inspector General 

Act of 1978, as amended, to make 

written requests under 5 U.S.C. 

552a(b)(7) for transfer of records 

maintained by other Federal agencies 

which are necessary to carry out an 

authorized law enforcement activity 

under the Inspector General Act of 1978, 

as amended. 

(b) The FHFA Inspector General 

delegates the authority under paragraph 

(a) of this section to the following 

FHFA–OIG officials— 

(1) Principal Deputy Inspector 

General; 

(2) Deputy Inspector General for 

Audits; 

(3) Deputy Inspector General for 

Investigations; 

(4) Deputy Inspector General for 

Evaluations; and 

(5) Deputy Inspector General for 

Administration. 

(c) The officials listed in paragraph (b) 

of this section may not further delegate 

or re-delegate the authority described in 

paragraph (a) of this section. 

Dated: August 11, 2011. 

Edward J. DeMarco, 

Acting Director, Federal Housing Finance 

Agency. 

[FR Doc. 2011–21250 Filed 8–18–11; 8:45 am] 

BILLING CODE 8070–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2011–M–0570] 

Medical Devices; Ophthalmic Devices; 

Classification of the Eyelid Thermal 

Pulsation System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

eyelid thermal pulsation system into 

class II (special controls). The Agency is 

classifying the device into class II 

(special controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. 

DATES: This rule is effective September 

19, 2011. The classification was 

effective on June 28, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Marc Robboy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2256, Silver Spring, 

MD 20993–0002, 301–796–6860. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976 (the 

date of enactment of the Medical Device 

Amendments of 1976), generally 

referred to as postamendments devices, 

are classified automatically by statute 

into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act (21 U.S.C. 

360c(i)), 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 part 807 of the 

regulations (21 CFR part 807). 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

July 12, 2010, classifying the LipiFlow®

Thermal Pulsation System into class III, 

because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

August 6, 2010, TearScience, Inc., 

submitted a petition requesting 

classification of the LipiFlow® Thermal 

Pulsation System under section 513(f)(2) 

of the FD&C Act. The manufacturer 

recommended that the device be 

classified into class II. (Ref. 1) 

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

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the petition, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name eyelid thermal pulsation system, 

and it is identified as an electricallypowered device intended for use in the 

application of localized heat and 

pressure therapy to the eyelids. The 

device is used in adult patients with 

chronic cystic conditions of the eyelids, 


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