53686 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33(a)(1) 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. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In 520.2215, revise paragraph (c)(3) 

to read as follows: 

§ 520.2215 Sulfadiazine/pyrimethamine 

suspension. 

* * * * * 

(c) * * * 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

Dated: September 5, 2008. 

William T. Flynn, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. E8–21625 Filed 9–16–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0310] 

Medical Devices; Medical Device 

Reporting; Baseline Reports; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of October 27, 2008, for 

the final rule that appeared in the 

Federal Register of June 13, 2008 (73 FR 

33692). The direct final rule amends the 

Medical Device Reporting regulation by 

removing the requirement for baseline 

reports. This document confirms the 

effective date of the direct final rule. 

DATES: Effective date confirmed: 

October 27, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Howard A. Press, Center for Devices and 

Radiological Health (HFZ–531), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276– 

3457. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 13, 2008 (73 FR 

33692), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending August 27, 2008. 

FDA stated that the effective date of the 

direct final rule would be on October 

27, 2008, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA did 

not receive any significant adverse 

comments. 

Authority: Therefore, under the Federal 

Food, Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food and 

Drugs, the amendments issued thereby 

become effective on October 27, 2008. 

Dated: September 11, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21756 Filed 9–16–08; 8:45 am] 

BILLING CODE 4160–01–S 

MILLENNIUM CHALLENGE 

CORPORATION 

22 CFR Part 1304 

Regulations Implementing the 

Freedom of Information Act 

AGENCY: Millennium Challenge 

Corporation. 

ACTION: Final rule. 

SUMMARY: The Millennium Challenge 

Corporation is issuing a final rule to 

update its Freedom of Information Act 

regulations. The purpose of this final 

rule is to outline the procedures by 

which the Millennium Challenge 

Corporation proposes to implement the 

relevant provisions of the Freedom of 

Information Act as required under that 

statute. This document will assist 

interested parties in obtaining access to 

Millennium Challenge Corporation 

public records. 

DATES: This final rule is effective on 

September 17, 2008. 

ADDRESSES: Send comments to John 

Mantini, FOIA Officer, Office of the 

General Counsel, Millennium Challenge 

Corporation, 875 Fifteenth Street, NW., 

Washington, DC 20005–2221. 

FOR FURTHER INFORMATION CONTACT: John 

Mantini, FOIA Officer, 202–521–3863. 

SUPPLEMENTARY INFORMATION: The 

Millennium Challenge Act (MCA) of 

2003 established a new federal agency 

called the Millennium Challenge 

Corporation. Congress enacted the 

Freedom of Information Act (FOIA) in 

1966 and last modified it with the 

Electronic Freedom of Information Act 

amendments of 1996. On August 28, 

2007, the Millennium Challenge 

Corporation published a proposed rule 

in the Federal Register, 72 FR 49238, 

Aug. 28, 2007 to outline its procedures 

to implement the FOIA regulations and 

requested public comments. The 

Millennium Challenge Corporation 

received no comments during the 60- 

day comment period. The Millennium 

Challenge Corporation’s final 

regulations are identical to those in the 

proposed rule. 

This final rule addresses 

electronically available documents, 

procedures for making requests, agency 

handling of requests, records not 

disclosed, changes in fees, and public 

reading rooms as well as other related 

provisions. 

List of Subjects in 22 Part 1304 

Freedom of Information Act 

Procedures. 

■ For the reasons set forth in the 

preamble, the Millennium Challenge 

Corporation adds 22 CFR part 1304 as 

follows: 

PART 1304—FREEDOM OF 

INFORMATION ACT PROCEDURES 

Sec. 

1304.1 General Provisions. 

1304.2 Definitions. 

1304.3 Records available to the public. 

1304.4 Requests for records. 

1304.5 Responsibility for responding to 

requests. 

1304.6 Records not disclosed. 

1304.7 Confidential commercial 

information. 

1304.8 Appeals. 

1304.9 Fees. 

Authority: 5 U.S.C. 552, as amended. 

§ 1304.1 General Provisions. 

This part contains the regulations the 

Millennium Challenge Corporation 

(MCC) follows in implementing the 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53687 

Freedom of Information Act (FOIA) (5 

U.S.C. 552) as amended. These 

regulations provide procedures by 

which you may obtain access to records 

compiled, created, and maintained by 

MCC, along with the procedures that 

MCC must follow in response to such 

requests for records. These regulations 

should be read together with the FOIA, 

which provides additional information 

about access to records maintained by 

MCC. 

§ 1304.2 Definitions. 

Agency has the meaning set forth in 

5 U.S.C. 552(f)(1). 

Commercial use requester means a 

requester seeking information for a use 

or purpose that furthers the commercial, 

trade, or profit interests of himself or the 

person on whose behalf the request is 

made, which can include furthering 

those interests through litigation. In 

determining whether a request properly 

belongs in this category, the FOIA 

Officer shall determine the use to which 

the requester will put the documents 

requested. Where the FOIA Officer has 

reasonable cause to doubt the use to 

which the requester will put the records 

sought, or where that use is not clear 

from the request itself, the FOIA Officer 

shall contact the requester for additional 

clarification before assigning the request 

to a specific category. 

Confidential commercial information 

means records provided to the 

government by a submitter that arguably 

contains material exempt from 

disclosure under Exemption 4 of the 

FOIA, because disclosure could 

reasonably be expected to cause 

substantial competitive harm. 

Direct costs mean those expenditures 

by MCC actually incurred in searching 

for and duplicating records in response 

to the FOIA request. These costs include 

the salary of the employee(s) performing 

the work (basic rate of pay plus a 

percentage of that rate to cover benefits) 

and the cost of operating duplicating 

machinery. Direct costs do not include 

overhead expenses, such as the cost of 

space, heating, or lighting of the facility 

in which the records are stored. 

Duplication means the process of 

making a copy of a record in order to 

respond to a FOIA request, including 

paper copies, microfilm, audio-video 

materials, and computer diskettes or 

other electronic copies. 

Educational institution refers to a 

preschool, a public or private 

elementary or secondary school, an 

institute of undergraduate higher 

education, an institute of graduate 

higher education, an institute of 

professional education, or an institute of 

vocational education which operates a 

program of scholarly research. To 

qualify for this category, the requester 

must show that the request is authorized 

by and is made under the auspices of a 

qualifying institution and that the 

records are not sought for a commercial 

use, but are sought to further scholarly 

research. 

FOIA means the Freedom of 

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

552). 

FOIA Officer means the MCC 

employee who is authorized to make 

determinations as provided in this part. 

The mailing address for the FOIA 

Officer is: Millennium Challenge 

Corporation, Attn: FOIA Officer, 875 

Fifteenth Street, NW., Washington, DC 

20005. 

Non-commercial scientific institution 

refers to an institution that is not 

operated on a ‘‘commercial’’ basis as 

that term is used in paragraph (a) of this 

section, and which is operated solely for 

the purpose of conducting scientific 

research the results of which are not 

intended to promote any particular 

product or industry. To qualify for this 

category, the requester must show that 

the request is authorized by and is made 

under the auspices of a qualifying 

institution and that the records are not 

sought for a commercial use, but are 

sought to further scholarly research. 

Record means information or 

documentary material MCC maintains 

in any form or format, including an 

electronic form or format, which MCC: 

(1) Made or received under federal 

law or in connection with the 

transaction of public business; 

(2) Preserved or determined is 

appropriate for preservation as evidence 

of MCC operations or activities or 

because of the value of the information 

it contains; and 

(3) Controls at the time it receives a 

request. 

Representative of the news media 

means any person actively gathering 

news for an entity that is organized and 

operated to publish or broadcast news to 

the public. The term ‘‘news’’ means 

information that is about current events 

or that would be of current interest to 

the public. For a ‘‘freelance journalist’’ 

to be regarded as working for a news 

organization, the requester must 

demonstrate a solid basis for expecting 

publication through that organization, 

such as a publication contract. Absent 

such showing, the requester may 

provide documentation establishing the 

requester’s past publication record. To 

qualify for this category, the requester 

must not be seeking the requested 

records for a commercial use. However, 

a request for records supporting a newsdissemination function shall not be 

considered to be for a commercial use. 

Requester means any person, 

including an individual, corporation, 

firm, organization, or other entity, who 

makes a request to MCC under FOIA for 

records. 

Review means the process of 

examining a record to determine 

whether all or part of the record may be 

withheld, and includes redacting or 

otherwise processing the record for 

disclosure to a requester. It does not 

include time spent: 

(1) Resolving legal or policy issues 

regarding the application of exemptions 

to a record; or 

(2) At the administrative appeal level, 

unless MCC determines that the 

exemption under which it withheld 

records does not apply and the records 

are reviewed again to determine 

whether a different exemption may 

apply. 

Search means the time spent locating 

records responsive to a request, 

manually or by electronic means, 

including page-by-page or line-by-line 

identification of responsive material 

within a record. 

Submitter means any person or entity 

which provides information directly or 

indirectly to MCC. The term includes, 

but is not limited to, corporations, state 

governments and foreign governments. 

Working day means a Federal 

workday that does not include 

Saturdays, Sundays, or Federal 

holidays. 

§ 1304.3 Records available to the public. 

(a) General. (1) It is the policy of MCC 

to respond promptly to all FOIA 

requests. 

(2) MCC may disclose records that 

were previously published or disclosed 

or are customarily furnished to the 

public in the course of the performance 

of official duties without complying 

with this part. These records include, 

but are not limited to, the annual report 

that MCC submits to Congress pursuant 

to section 613(a) of the Millennium 

Challenge Act of 2003 (22 U.S.C. 7701), 

press releases, MCC forms, and 

materials published in the Federal 

Register. MCC should first determine 

whether the information requested is 

already available on its Web site, which 

contains information readily accessible 

to the public. In such an event, MCC 

will contact the requesting party, either 

orally or in writing, to advise the 

individual of the availability of the 

information on the public Web site. 

MCC should document this request and 

the manner in which it handled the file. 

Where MCC makes the determination 

that the information requested is not 

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already publicly accessible, MCC should 

adhere to the procedures outlined in 

this part for processing a FOIA request 

and any administrative appeals 

received. 

(b) Public Reading room. (1) Records 

that are required to be maintained by 

MCC shall be available for public 

inspection and copying at 875 Fifteenth 

Street, NW., Washington, DC 20005. 

Reading room records created on or after 

November 1, 1996 shall be made 

available electronically via the Web site 

at http://www.mcc.gov. 

(2) MCC shall assess fees for 

searching, reviewing, or duplicating 

reading room records in accordance 

with § 1304.9. 

§ 1304.4 Requests for records. 

(a) Request requirements. Requests for 

access to, or copies of, MCC records 

shall be in writing and addressed to the 

FOIA Officer. Each request shall include 

the following: 

(1) A description of the requested 

record that provides sufficient detail to 

enable MCC to locate the record with a 

reasonable amount of effort; 

(2) The requestor’s full name, mailing 

address, and a telephone number where 

the requester can be reached during 

normal business hours; 

(3) A statement that the request is 

made pursuant to FOIA; and 

(4) At the discretion of the requestor, 

a dollar limit on the fees MCC may 

incur to respond to the request for 

records. MCC shall not exceed such 

limit. 

(b) Incomplete Requests. If a request 

does not meet all of the requirements of 

paragraph (a) of this section, the FOIA 

Officer may advise the requester that 

additional information is needed. If the 

requester submits a corrected request, 

the FOIA Officer shall treat the 

corrected request as a new request. 

§ 1304.5 Responsibility for responding to 

requests. 

(a) General. In determining which 

records are responsive to a request, MCC 

ordinarily will include only records in 

its possession as of the date it begins its 

search for records. If any other date is 

used, the FOIA Officer shall inform the 

requester of that date. 

(b) Authority to grant or deny 

requests. The FOIA Officer shall make 

initial determinations either to grant or 

deny in whole or in part a request for 

records. When the FOIA Officer denies 

the request in whole or in part, the 

FOIA Officer shall notify the requester 

of the denial, the grounds for the denial, 

and the procedures for appeal of the 

denial under § 1304.8. 

(c) Consultations and referrals. When 

a requested record has been created by 

another Federal Government agency, 

that record shall be referred to the 

originating agency for direct response to 

the requester. The requester shall be 

informed of the referral. As this is not 

a denial of a FOIA request, no appeal 

rights are afforded to the requester. 

When a requested record is identified as 

containing information originating with 

another Federal Government agency, the 

record shall be referred to the 

originating agency for review and 

recommendation on disclosure. 

(d) Timing and deadlines. (1) The 

FOIA Officer ordinarily shall respond to 

requests according to their order of 

receipt. 

(2) The FOIA Officer may use multitrack processing in responding to 

requests. This process entails separating 

simple requesters that require rather 

limited review from more lengthy and 

complex requests. Requests in each 

track are then processed according to 

paragraph (d)(1) of this section in their 

respective track. 

(3) The FOIA Officer may provide 

requesters in the slower track an 

opportunity to limit the scope of their 

requests in order to decrease the 

processing time required. The FOIA 

Officer may provide such an 

opportunity by contacting the requester 

by letter or telephone. 

(4) The FOIA Officer shall make an 

initial determination regarding access to 

the requested information and notify the 

requester within twenty (20) working 

days after receipt of the request. This 20 

day period may be extended if unusual 

circumstances arise. If an extension is 

necessary, the FOIA Officer shall 

promptly notify the requester of the 

extension, briefly providing the reasons 

for the extension, the date by which a 

determination is expected, and 

providing the requester with the 

opportunity to modify the request so 

that the FOIA Officer may process it in 

accordance with the 20 day period. 

Unusual circumstances warranting 

extension are: 

(i) The need to search for and collect 

the requested records from field 

facilities or other establishments that are 

separate from the officeprocessing the 

request; 

(ii) The need to search for, collect, 

and appropriately examine a lengthy 

amount of records which are demanded 

in a single request; or 

(iii) The need for consultation with 

another agency having a substantial 

interest in the determination of the 

request, which consultation shall be 

conducted with all practicable speed. 

(iv) If the FOIA Officer has a 

reasonable basis to conclude that a 

requester or group of requesters has 

divided a request into a series of 

requests on a single subject or related 

subject to avoid fees, the requests may 

be aggregated and fees charged 

accordingly. Multiple requests involving 

unrelated matters will not be aggregated. 

(5) If no initial determination has 

been made at the end of the 20 day 

period provided for in paragraph (d)(4) 

of this section, including any extension, 

the requester may appeal the action to 

the FOIA Appeals Officer. 

(e) Expedited processing of request. 

The FOIA Officer must determine 

whether to grant a request for expedited 

processing within 10 calendar days of 

its receipt. Requests will receive 

expedited processing if one of the 

following listed compelling reasons is 

met: 

(1) The requester can establish that 

failure to receive the records quickly 

could reasonably be expected to pose an 

imminent threat to the life or physical 

safety of an individual; or 

(2) The requester is primarily engaged 

in disseminating information and can 

demonstrate that an urgency to inform 

the public concerning actual or alleged 

Federal Government activity exists. 

(f) Providing responsive records. The 

FOIA Officer shall provide one copy of 

a record to a requester in any form or 

format requested if the record is readily 

reproducible by MCC in that form or 

format by regular U.S. mail to the 

address indicated in the request, unless 

other arrangements are made. At the 

option of the requester and upon the 

requester’s agreement to pay fees in 

accordance with § 1304.9, the FOIA 

Officer shall provide copies by facsimile 

transmission or other express delivery 

methods. 

§ 1304.6 Records not disclosed. 

(a) Records exempt from disclosure. 

Except as otherwise provided in this 

part, MCC shall not disclose records that 

are: 

(1) Specifically authorized under 

criteria established by an Executive 

order to be kept secret in the interest of 

national defense or foreign policy and 

are in fact properly classified pursuant 

to such Executive order. 

(2) Related solely to the MCC’s 

internal personnel rules and practices. 

(3) Specifically exempted from 

disclosure by a statute other than FOIA 

if such statute requires the record to be 

withheld from the public in such a 

manner as to leave no discretion on the 

issue, establishes particular criteria for 

withholding, or refers to particular types 

of records to be withheld. 

(4) Trade secrets and commercial or 

financial information obtained from a 

person and privileged or confidential. 

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(5) Inter- or intra-agency 

memorandums or letters that would not 

be available by law to a party other than 

an agency in litigation with MCC. 

(6) Personnel, medical, or similar files 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

(7) Compiled for law enforcement 

purposes, but only to the extent that the 

production of such law enforcement 

records or information: 

(i) Could reasonably be expected to 

interfere with enforcement proceedings; 

(ii) Would deprive a person of a right 

to a fair trial or an impartial 

adjudication; 

(iii) Could reasonably be expected to 

constitute an unwarranted invasion of 

personal privacy; 

(iv) Could reasonably be expected to 

disclose the identity of a confidential 

source, including a State, local, or 

foreign agency or authority, any private 

institution, or a Bank, which furnished 

information on a confidential basis, and, 

in the case of a record compiled by 

criminal law enforcement authority in 

the course of a criminal investigation or 

by an agency conducting a lawful 

national security investigation, 

information furnished by a confidential 

source; 

(v) Would disclose techniques and 

procedures for law enforcement 

investigations or prosecutions, or would 

disclose guidelines for law enforcement 

investigations or prosecutions if such 

disclosure could reasonably be expected 

to risk circumvention of the law; or 

(vi) Could reasonably be expected to 

endanger the life or physical safety of 

any individual. 

(8) Contained in or related to 

examination, operating, or condition 

reports prepared by, on behalf of, or for 

the use of an agency responsible for the 

regulation or supervision of financial 

institutions; or 

(9) Geological and geophysical 

information and data, including maps, 

concerning wells. 

(b) Reasonably segregable portions. (1) 

MCC shall provide a requester with any 

reasonably segregable portion of a 

record after deleting the portions that 

are exempt from disclosure under 

paragraph (a) of this section. 

(2) MCC shall make a reasonable effort 

to estimate the volume of removed 

information and provide that 

information to the requester unless 

providing the estimate would harm an 

interest protected by the exemption 

under which the removal is made. 

(3) MCC shall indicate the estimated 

volume of removed information on the 

released portion of the record unless 

providing the estimate would harm an 

interest protected by the exemption 

under which the removal is made. If 

technically feasible, MCC shall make the 

indication at the place in the record 

where the removal is made. 

(c) Public interest. MCC may disclose 

records it has authority to withhold 

under paragraph (a) of this section upon 

a determination that disclosure would 

be in the public interest. 

§ 1304.7 Confidential commercial 

information. 

(a) Notice to submitters. The FOIA 

Officer shall, to the extent permitted by 

law, provide a submitter who provides 

confidential commercial information to 

the FOIA Officer, with prompt notice of 

a FOIA request or administrative appeal 

encompassing the confidential 

commercial information if the 

Commission may be required to disclose 

the information under the FOIA. Such 

notice shall either describe the exact 

nature of the information requested or 

provide copies of the records or portions 

thereof containing the confidential 

commercial information. The FOIA 

Officer shall also notify the requester 

that notice and an opportunity to object 

has been given to the submitter. 

(b) Where notice is required. Notice 

shall be given to a submitter when: 

(1) The information has been 

designated by the submitter as 

confidential commercial information 

protected from disclosure. Submitters of 

confidential commercial information 

shall use good faith efforts to designated 

either at the time of submission or a 

reasonable time thereafter, those 

portions of their submissions they deem 

protected from disclosure under 

Exemption 4 of the FOIA because 

disclosure could reasonably be expected 

to cause substantial competitive harm. 

Such designation shall be deemed to 

have expired ten years after the date of 

submission, unless the requester 

provides reasonable justification for a 

designation period of greater duration; 

or 

(2) The FOIA Officer has reason to 

believe that the information may be 

protected from disclosure under 

Exemption 4 of the FOIA. 

(c) Opportunity to object to disclosure. 

The FOIA Officer shall afford a 

submitter a reasonable period of time to 

provide the FOIA Officer with a detailed 

written statement of any objection to 

disclosure. The statement shall specify 

all grounds for withholding any of the 

information under any exemption of the 

FOIA, and if Exemption 4 applies, shall 

demonstrate the reasons the submitter 

believes the information to be 

confidential commercial information 

that is exempt from disclosure. 

Whenever possible, the submitter’s 

claim of confidentiality shall be 

supported by a statement or certification 

by an officer or authorized 

representative of the submitter. In the 

event a submitter fails to respond to the 

notice in the time specified, the 

submitter will be considered to have no 

objection to the disclosure of the 

information. Information provided by 

the submitter that is received after the 

disclosure decision has been made will 

not be considered. Information provided 

by a submitter pursuant to this 

paragraph may itself be subject to 

disclosure under the FOIA. 

(d) Notice of intent to disclose. The 

FOIA Officer shall carefully consider a 

submitter’s objections and specific 

grounds for nondisclosure prior to 

determining whether to disclose the 

information requested. Whenever the 

FOIA Officer determines that disclosure 

is appropriate, the FOIA Officer shall, 

within a reasonable number of days 

prior to disclosure, provide the 

submitter with written notice of the 

intent to disclose which shall include a 

statement of the reasons for which the 

submitter’s objections were overruled, a 

description of the information to be 

disclosed, and a specific disclosure 

date. The FOIA Officer shall also notify 

the requester that the requested records 

will be made available. 

(e) Notice of lawsuit. If the requester 

files a lawsuit seeking to compel 

disclosure of confidential commercial 

information, the FOIA Officer shall 

promptly notify the submitter of this 

action. If a submitter files a lawsuit 

seeking to prevent disclosure of 

confidential commercial information, 

the FOIA Officer shall notify the 

requester. 

(f) Exceptions to the notice 

requirements under this section. The 

notice requirements under paragraphs 

(a) and (b) of this section shall not apply 

if: 

(1) The FOIA Officer determines that 

the information should not be disclosed 

pursuant to Exemption 4 and/or any 

other exemption of the FOIA; 

(2) The information lawfully has been 

published or officially made available to 

the public; 

(3) Disclosure of the information is 

required by law (other than the FOIA); 

(4) The information requested is not 

designated by the submitter as exempt 

from disclosure in accordance with this 

part, when the submitter had the 

opportunity to do so at the time of 

submission of the information or within 

a reasonable time thereafter, unless the 

agency has substantial reason to believe 

that disclosure of the information would 

result in competitive harm; or 

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53690 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

(5) The designation made by the 

submitter in accordance with this part 

appears obviously frivolous. When the 

FOIA Officer determines that a 

submitter was frivolous in designating 

information as confidential, the FOIA 

Officer must provide the submitter with 

written notice of any final 

administrative disclosure date, but no 

opportunity to object to disclosure will 

be offered. 

§ 1304.8 Appeals. 

(a) Right of appeal. The requester has 

the right to appeal to the FOIA Appeals 

Officer any adverse determination. 

(b) Notice of appeal—(1) Timing for 

appeal. An appeal must be received no 

later than thirty (30) working days after 

notification of denial of access to 

records or after the time limit for 

response by the FOIA Officer has 

expired. Prior to submitting an appeal 

any outstanding fees related to FOIA 

requests must be paid in full. 

(2) Method of appeal. An appeal shall 

be initiated by filing a written notice of 

appeal. The notice shall be 

accompanied by copies of the original 

request and initial denial of access to 

records. To expedite the appellate 

process and give the requester an 

opportunity to present his or her 

arguments, the notice should contain a 

brief statement of the reasons why the 

requester believes the initial denial of 

access to records was in error. The 

appeal shall be addressed to the 

Millennium Challenge Corporation, 

Attn: FOIA Appeals Officer, 875 

Fifteenth Street, NW., Washington, DC 

20005. 

(c) Final agency determinations. The 

FOIA Appeals Officer shall issue a final 

written determination, stating the basis 

for his or her decision, within twenty 

(20) working days after receipt of a 

notice of appeal. If the determination is 

to provide access to the requested 

records, the FOIA Officer shall make 

those records immediately available to 

the requester. If the determination 

upholds the denial of access to the 

requested records, the FOIA Appeals 

Officer shall notify the requester of the 

determination. 

§ 1304.9 Fees. 

(a) General. Fees pursuant to the FOIA 

shall be assessed according to the 

schedule contained in paragraph (b) of 

this section for services rendered by 

MCC in response to requests for records 

under this part. MCC’s fee practices are 

governed by the FOIA and by the Office 

of Management and Budget’s Uniform 

Freedom of Information Act Fee 

Schedule and Guidelines. All fees shall 

be charged to the requester, except 

where the charging of fees is limited 

under paragraph (d) of this section or 

where a waiver or reduction of fees is 

granted under paragraph (c) of this 

section. Payment of fees should be in 

U.S. Dollars in the form of either a 

check or bank draft drawn on a bank in 

the United States or a money order. 

Payment should be made payable to the 

Treasury of the United States and 

mailed to the Millennium Challenge 

Corporation, 875 Fifteenth Street, NW., 

Washington, DC 20005. 

(b) Charges for responding to FOIA 

requests. The following fees shall be 

assessed in responding to requests for 

records submitted under this part, 

unless a waiver or reduction of fees has 

been granted pursuant to paragraph (c) 

of this section: 

(1) Duplications. The FOIA Officer 

shall charge $0.20 per page for copies of 

documents up to 81⁄2 x 14. For copies 

prepared by computer, the FOIA Officer 

will charge actual costs of production of 

the computer printouts, including 

operator time. For other methods of 

reproduction, the FOIA Officer shall 

charge the actual costs of producing the 

documents. 

(2) Searches—(i) Manual searches. 

Search fees will be assessed at the rate 

of $25.30 per hour. Charges for search 

time less than a full hour will be in 

increments of quarter hours. 

(ii) Computer searches. The FOIA 

Officer will charge the actual direct 

costs of conducting computer searches. 

These direct costs shall include the cost 

of operating the central processing unit 

for that portion of operating time that is 

directly attributable to searching for 

requested records, as well as the costs 

of operator/programmer salary 

apportionable to the search. MCC is not 

required to alter or develop 

programming to conduct searches. 

(3) Review fees. Review fees shall be 

assessed only with respect to those 

requesters who seek records for a 

commercial use under paragraph (d)(1) 

of this section. Review fees shall be 

assessed at the rate of $43.63 per hour. 

Review fees shall be assessed only for 

the initial record review, for example, 

review undertaken when the FOIA 

Officer analyzes the applicability of a 

particular exemption to a particular 

record or portion thereof at the initial 

request level. No charge shall be 

assessed at the administrative appeal 

level of an exemption already applied. 

(c) Statutory waiver. Documents shall 

be furnished without charge or at a 

charge below that listed in paragraph (b) 

of this section where it is determined, 

based upon information provided by a 

requester or otherwise made known to 

the FOIA Officer, that disclosure of the 

requested information is in the public 

interest. Disclosure is in the public 

interest if it is likely to contribute 

significantly to public understanding of 

government operations and is not 

primarily for commercial purposes. 

Requests for a waiver or reduction of 

fees shall be considered on a case-bycase basis. In order to determine 

whether the fee waiver requirement is 

met, the FOIA Officer shall consider the 

following six factors: 

(1) The subject of the request. 

Whether the subject of the requested 

records concerns the operations or 

activities of the government; 

(2) The informative value of the 

information to be disclosed. Whether 

disclosure is likely to contribute to an 

understanding of government operations 

or activities; 

(3) The contribution to an 

understanding of the subject by the 

general public likely to result from 

disclosure. Whether disclosure of the 

requested information will contribute to 

public understanding; 

(4) The significance of the 

contribution to public understanding. 

Whether the disclosure is likely to 

contribute significantly to public 

understanding of government operations 

or activities; 

(5) The existence and magnitude of 

commercial interest. Whether the 

requester has a commercial interest that 

would be furthered by the requested 

disclosure; and, if so 

(6) The primary interest in disclosure. 

Whether the magnitude of the identified 

commercial interest of the requester is 

sufficiently large, in comparison with 

the public interest in disclosure, that 

disclosure is primarily in the 

commercial interest of the requester. 

(d) Types of requesters. There are four 

categories of FOIA requesters: 

Commercial use requesters; educational 

and non-commercial scientific 

institutional requesters; representatives 

of the news media; and all other 

requesters. These terms are defined in 

§ 1304.2. The following specific levels 

of fees are prescribed for each of these 

categories: 

(1) Commercial use requesters. The 

FOIA Officer shall charge commercial 

use requesters the full direct costs of 

searching for, reviewing, and 

duplicating requested records. 

(2) Educational and non-commercial 

scientific institution requesters. The 

FOIA Officer shall charge educational 

and non-commercial scientific 

institution requesters for document 

duplication only, except that the first 

100 pages of paper copies shall be 

provided without charge. 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53691 

(3) News media requesters. The FOIA 

Officer shall charge news media 

requesters for document duplication 

costs only, except that the first 100 

pages of paper copies shall be provided 

without charge. 

(4) All other requesters. The FOIA 

Officer shall charge requesters who do 

not fall into any of the categories in 

paragraphs (d)(1) through (3) of this 

section fees which recover the full 

reasonable direct costs incurred for 

searching for and reproducing records if 

that total cost exceeds $14.99, except 

that the first 100 pages of duplication 

and the first two hours of manual search 

time shall not be charged. 

(e) Charges for unsuccessful searches. 

If the requester has been notified of the 

estimated cost of the search time and 

has been advised specifically that the 

requested records may not exist or may 

be withheld as exempt, fees may be 

charged. 

(f) Nonpayment of fees. The FOIA 

Officer may assess interest charges on 

an unpaid bill, accrued under previous 

FOIA request(s), starting the thirty-first 

(31st) day following the day on which 

the bill was sent to the requester. 

Interest will be at the rate prescribed in 

31 U.S.C. 3717. MCC will require the 

requester to pay the full amount owed 

plus any applicable interest as provided 

above, and to make an advance payment 

of the full amount of the remaining 

estimated fee before MCC will begin to 

process a new request or continue 

processing a then-pending request from 

the requester. The administrative 

response time limits prescribed in 

subsection (a)(6) of the FOIA will begin 

only after MCC has received fee 

payments described in this section. 

(g) Aggregating requests. The 

requester or a group of requesters may 

not submit multiple requests at the same 

time, each seeking portions of a 

document or documents solely in order 

to avoid payment of fees. When the 

FOIA Officer reasonably believes that a 

requester is attempting to divide a 

request into a series of requests to evade 

an assessment of fees, the FOIA Officer 

may aggregate such request and charge 

accordingly. 

(h) Advance payment of fees. Fees 

may be paid upon provision of the 

requested records, except that payment 

will be required prior to that time if the 

requester has previously failed to pay 

fees or if the FOIA Officer determines 

the total fee will exceed $250.00. When 

payment is required in advance of the 

processing of a request, the time limits 

prescribed in § 1304.5 shall not be 

deemed to begin until the FOIA Officer 

has received payment of the assessed 

fee. Where it is anticipated that the cost 

of providing the requested record will 

exceed $25.00 but fall below $250.00 

after the free duplication and search 

time has been calculated, MCC may, in 

its discretion may require either: 

(1) An advance deposit of the entire 

estimated charges; or 

(2) Written confirmation of the 

requester’s willingness to pay such 

charges. 

Dated: September 5, 2008. 

John C. Mantini, 

Chief FOIA Officer, Millennium Challenge 

Corporation. 

[FR Doc. E8–21335 Filed 9–16–08; 8:45 am] 

BILLING CODE 9211–03–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 138 

[Docket No. USCG–2005–21780] 

RIN 1625–AA98 

Financial Responsibility for Water 

Pollution (Vessels) and OPA 90 Limits 

of Liability (Vessels and Deepwater 

Ports) 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

the regulatory requirements, under the 

Oil Pollution Act of 1990 and the 

Comprehensive Environmental 

Response, Compensation and Liability 

Act, for vessel operators (as defined in 

the rule) to establish and maintain 

evidence of financial responsibility. The 

amendments ensure that the amounts of 

financial responsibility that must be 

demonstrated by vessel operators are 

consistent with recent statutory 

increases, and future mandated 

increases, to the limits of liability under 

the Oil Pollution Act of 1990. The 

amendments also implement changes in 

the Coast Guard’s administration of the 

certificate of financial responsibility 

program, and clarify the current rule. 

DATES: This final rule is effective 

October 17, 2008. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2005–21780 and are 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call 

Benjamin White, National Pollution 

Funds Center, Coast Guard, telephone 

202–493–6863. If you have questions on 

viewing the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

I. Acronyms 

CERCLA Title I of the Comprehensive 

Environmental Response, Compensation, and 

Liability Act of 1980, as amended (42 U.S.C. 

9601–9675). 

CFR Code of Federal Regulations. 

COFR Certificate of Financial 

Responsibility. 

DPA Deepwater Port Act of 1974, as 

amended (33 U.S.C. 1501 et seq.). 

DRPA Delaware River Protection Act of 

2006, Title VI of the Coast Guard and 

Maritime Transportation Act of 2006, Public 

Law 109–241, July 11, 2006, 120 Stat. 516. 

FRFA Final Regulatory Flexibility 

Analysis. 

FR Federal Register. 

Fund Oil Spill Liability Trust Fund. 

IRFA Initial Regulatory Flexibility 

Analysis. 

LOOP Louisiana Offshore Oil Port. 

MODU Mobile Offshore Drilling Unit. 

NEPA National Environmental Policy Act 

of 1969 (42 U.S.C. 4321–4370f). 

NPRM Notice of Proposed Rulemaking. 

OPA 90 The Oil Pollution Act of 1990, as 

amended (33 U.S.C. 2701, et seq.). 

U.S.C. United States Code. 

U.S.C.C.A.N. United States Code 

Congressional and Administrative News. 

II. Regulatory History 

On August 18, 2006, before initiating 

this rulemaking, we published a notice 

of policy in the Federal Register (71 FR 

47737) entitled ‘‘New Oil Pollution 

Limits of Liability for Vessels— 

Delaware River Protection Act of 2006 

Amendment to the Oil Pollution Act of 

1990’’ (hereafter the ‘‘Notice of Policy’’). 

On February, 5, 2008, we published a 

notice of proposed rulemaking (NPRM) 

in the Federal Register (73 FR 6642), 

entitled ‘‘Financial Responsibility for 

Water Pollution (Vessels) and OPA 90 

Limits of Liability (Vessels and 

Deepwater Ports)’’. 

On February 13, 2008, we published 

corrections to the NPRM in the Federal 

Register (73 FR 8250), to clarify the 

proposed effective date of the rule and 

the distinction between the financial 

responsibility applicable amounts of 

§ 138.80(f) and the OPA 90 limits of 

liability in proposed Subpart B. 

We received seven letters during the 

public comment period raising 13 

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