45500 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by November 28, 

2017. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Particulate matter, 

Reporting and recordkeeping 

requirements, Sulfur oxides. 

Dated: September 19, 2017. 

Catherine R. McCabe, 

Acting Regional Administrator, Region 2. 

Part 52 chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart HH—New York 

■ 2. In § 52.1670(e) the table titled ‘‘EPA 

APPROVED NEW YORK 

NONREGULATORY AND QUASIREGULATORY PROVISIONS’’ is 

amended by adding the entry ‘‘Regional 

Haze Five-Year Progress Report’’ at the 

end of the table to read as follows: 

§ 52.1670 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED NEW YORK NONREGULATORY AND QUASI-REGULATORY PROVISIONS

SIP element Applicable geographic 

or nonattainment area 

New York 

submittal date 

EPA 

approval date Explanation 

*******

Regional Haze Five-Year Progress Report.State-wide .................. June 16, 2015 ...... September 29, 2017; [Insert Federal 

Register page citation].

[FR Doc. 2017–20823 Filed 9–28–17; 8:45 am] 

BILLING CODE 6560–50–P 

CHEMICAL SAFETY AND HAZARD 

INVESTIGATION BOARD 

40 CFR Part 1601 

[Agency Docket Number CSB 17–1] 

Freedom of Information Act Program 

AGENCY: Chemical Safety and Hazard 

Investigation Board. 

ACTION: Interim final rule. 

SUMMARY: This interim final rule revises 

the Chemical Safety and Hazard 

Investigation Board’s (CSB) Freedom of 

Information Act (FOIA) rule. The 

purpose of this revision is to ensure 

consistency with the FOIA 

Improvement Act of 2016 and to update 

certain other provisions of the CSB’s 

current rule. This interim final rule 

supersedes all previous CSB rules and 

guidance that supplement and 

implement the CSB FOIA Program. 

DATES:

Effective date: This rule is effective 

September 29, 2017. 

Comment date: Comments must be 

received by October 30, 2017. 

ADDRESSES: You may send comments by 

any of the following methods: 

(a) Email to: kara.wenzel@csb.gov. In 

the subject line of the message include 

‘‘Comment—Interim Final FOIA Rule.’’ 

(b) Fax: 202–261–7650, attention: 

Kara Wenzel, Acting General Counsel, 

Chemical Safety and Hazard 

Investigation Board. 

(c) Mail to: Kara Wenzel, Acting 

General Counsel, Chemical Safety and 

Hazard Investigation Board, 1750 

Pennsylvania Ave. NW., Suite 910, 

Washington, DC 20006. 

(d) Hand Delivery/Courier: Kara 

Wenzel, Acting General Counsel, 

Chemical Safety and Hazard 

Investigation Board, 1750 Pennsylvania 

Ave. NW., Suite 910, Washington, DC 

20006. 

Instructions: All submissions must 

include the title ‘‘Interim Final FOIA 

Rule’’ and the agency docket number for 

this rulemaking, CSB 17–1. The CSB 

will post all comments received by the 

due date to the CSB’s Web site, http:// 

www.csb.gov/, including any personal 

information provided. For additional 

details on submitting comments, see 

‘‘Public Participation’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket information: For access to the 

docket to read a compilation of all 

comments submitted, please visit http:// 

www.csb.gov/ after the final date for 

submission of comments. 

FOR FURTHER INFORMATION CONTACT: Kara 

Wenzel, Acting General Counsel, 202– 

261–7600, or kara.wenzel@csb.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

The FOIA, 5 U.S.C. 552, establishes 

basic procedures for public access to 

agency records. The FOIA requires 

federal agencies to issue regulations to 

establish procedures to implement the 

FOIA. The CSB’s current FOIA rule is 

codified at 40 CFR part 1601. 

This interim rule revises 40 CFR part 

1601 to implement provisions of the 

FOIA Improvement Act of 2016 and to 

make additional legal updates. 

Specifically, this interim rule 

implements changes to conform to the 

requirements of the following 

amendments to the FOIA since the 

adoption of the CSB’s current FOIA 

rule: The OPEN Government Act of 

2007, Public Law 110–175, the OPEN 

FOIA Act of 2009, Public Law 111–83, 

and the FOIA Improvement Act of 2016, 

Public Law 114–185. 

For example, the FOIA Improvement 

Act of 2016 introduced several changes 

to current law, including, but not 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45501 

limited to the following: An increase in 

the minimum time for an administrative 

appeal to ninety (90) day; increased 

opportunities for dispute resolution 

services at various times throughout the 

FOIA process; waiver of fees if agencies 

do not meet mandated time limits; 

proactive disclosure of records of 

general interest to the public that are 

appropriate for such disclosure; and 

application of the Department of 

Justice’s ‘‘foreseeable harm’’ standard as 

the basis for withholding information 

pursuant to a FOIA exemption, 5 U.S.C. 

552(a)(8)(A)(i)(I). 

Public Participation 

The CSB is issuing an interim final 

rule to revise its current FOIA 

regulation because these changes are 

required by statutory amendments to 

FOIA since the adoption of the CSB’s 

original FOIA rule in 2000. By issuing 

an interim final rule, these regulatory 

changes will take effect sooner than 

would be possible with the publication 

of a Notice of Proposed Rulemaking. 

Even though the CSB has issued an 

interim final rule, the CSB welcomes 

public comments from interested 

persons regarding any aspect of the 

changes made by this interim final rule. 

Please refer to the ADDRESSES section 

above for guidance on submitting 

comments. The CSB will consider all 

public comments in drafting the final 

rule. 

All comments must be submitted in 

English, or if not, accompanied by an 

English translation. 

Please note that all comments 

received are considered part of the 

public record and will be made 

available for public inspection online at 

http://www.csb.gov/disclaimers/legalaffairs-foia. Posted information made 

available on the CSB Web site will 

include personal identifying 

information (such as name and address) 

voluntarily submitted by the 

commenter, unless the CSB receives a 

specific request as described below to 

withhold such information. 

If you want to submit personal 

identifying information (such as your 

name and address) as part of your 

comment, but do not want it to be 

posted online, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You also must locate 

all the personal identifying information 

you do not want posted online in the 

first paragraph of your comment and 

identify what information you want 

redacted. If you want to submit 

confidential business information as 

part of your comment, but do not want 

it to be posted online, you must include 

the phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You also must 

prominently identify any confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted on http://

www.csb.gov/. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be placed in the agency’s records, 

but not posted online. 

The CSB reserves the right, but has no 

obligation, to review, pre-screen, filter, 

redact, refuse or remove any or all of 

your submission from http://

www.csb.gov/ that it may deem to be 

inappropriate for publication, such as 

obscene language. All submissions that 

have been redacted or removed that 

contain comments on the merits of the 

rulemaking will be retained in the 

rulemaking record and will be 

considered as required under the 

Administrative Procedure Act and other 

applicable laws, and may be accessible 

under the FOIA. 

Regulatory Procedures 

Administrative Procedure Act (5 U.S.C. 

Ch. 5) 

The CSB’s implementation of this rule 

as an interim final rule, with provision 

for post-promulgation public comment, 

is based on section 553(b) of the 

Administrative Procedure Act. 5 U.S.C. 

553(b). Under section 553(b), an agency 

may issue a rule without notice of 

proposed rulemaking and the prepromulgation opportunity for public 

comment, with regard to ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice.’’ The CSB has determined 

that many of the revisions are to 

interpretive rules issued by the CSB, as 

they merely advise the public of the 

CSB’s implementation of recent 

amendments to the FOIA. Moreover, the 

CSB has determined that the remaining 

revisions are rules of agency procedure 

or practice, as they do not change the 

substantive standards the agency 

applies in implementing the FOIA. The 

CSB has also concluded that there is 

good cause to find that a pre-publication 

public comment period is unnecessary. 

These revisions to the existing 

regulations in 40 CFR part 1601 merely 

implement statutory changes, align the 

CSB’s regulations with controlling 

judicial decisions, and clarify agency 

procedures. 

Unfunded Mandates Reform Act 

(2 U.S.C. Ch. 25) 

This interim final rule is not subject 

to the Unfunded Mandates Reform Act 

because it does not contain a Federal 

mandate that may result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000.00 or 

more in any one year. Nor will it have 

a significant or unique effect on small 

governments. 

Regulatory Flexibility Act (5 U.S.C. 

Ch. 6) 

This interim final rule is not subject 

to the Regulatory Flexibility Act. The 

CSB has reviewed this regulation and by 

approving it certifies that this regulation 

will not have a significant economic 

impact on a substantial number of small 

entities. The rule implements the 

procedures for processing FOIA requests 

within the CSB. Under the FOIA, 

agencies may recover only the direct 

costs of searching for, reviewing, and 

duplicating the records processed for 

the requesters. Thus, fees accessed by 

CSB will be nominal. Further, the 

‘‘small entities’’ that make FOIA 

requests, as compared with individual 

and other requesters, are relatively few 

in number. 

Paperwork Reduction Act (44 U.S.C. 

Ch. 35) 

This interim final rule does not 

impose reporting or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995. The Paperwork 

Reduction Act imposes certain 

requirements on Federal agencies in 

connection with the conducting or 

sponsoring of any collection of 

information. This interim rule does not 

contain any new collection of 

information requirement within the 

meaning of the Act. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. Ch. 6) 

This rule is not a major rule as 

defined by section 251 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (as amended), 5 

U.S.C. 804. This rule will not result in 

an annual effect on the economy of 

$100,000,000.00 or more; a major 

increase in costs or prices; or significant 

adverse effects on competition, 

employment, investment, productivity, 

innovation, or on the ability of United 

States-based enterprises to compete 

with foreign-based enterprises in 

domestic and export markets. 


asabaliauskas on DSKBBXCHB2PROD with RULES
45502 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

National Environmental Policy Act of 

1969 (5 U.S.C. 804) 

This interim final rule will not have 

significant effect on the human 

environment. Accordingly, this rule is 

categorically excluded from 

environmental analysis under 43 CFR 

46.210(i). 

E-Government Act of 2002 (44 U.S.C. 

3504) 

Section 206 of the E-Government Act 

requires agencies, to the extent 

practicable, to ensure that all 

information about that agency required 

to be published in the Federal Register 

is also published on a publicly 

accessible Web site. All information 

about the CSB required to be published 

in the Federal Register may be accessed 

at http://www.csb.gov/. This Act also 

requires agencies to accept public 

comments ‘‘by electronic means.’’ See 

the ‘‘Public Participation’’ heading of 

the SUPPLEMENTARY INFORMATION section 

of this document, for directions on the 

electronic submission of public 

comments on this interim final rule. 

Finally, the E-Government Act 

requires, to the extent practicable, that 

agencies ensure that a publicly 

accessible Federal Government Web site 

contains electronic dockets for 

rulemakings under the Administrative 

Procedure Act of 1946 (5 U.S.C. 551 et 

seq.). Under this Act, an electronic 

docket consists of all submissions under 

section 553(c) of title 5, United States 

Code; and all other materials that by 

agency rule or practice are included in 

the rulemaking docket under section 

553(c) of title 5, United States Code, 

whether or not submitted electronically. 

The Web site http://www.csb.gov/ will 

contain an electronic dockets for this 

rulemaking. 

Plain Writing Act of 2010 (5 U.S.C. 301) 

Under this Act, the term ‘‘plain 

writing’’ means writing that is clear, 

concise, well-organized, and follows 

other best practices appropriate to the 

subject or field and intended audience. 

To ensure that this rulemaking has been 

written in plain and clear language so 

that it can be used and understood by 

the public, the CSB has modeled the 

language of this interim final rule on the 

Federal Plain Language Guidelines. 

List of Subjects in 40 CFR Part 1601 

Administrative practice and 

procedure, Archives and records, 

Confidential business information, 

Freedom of information, Privacy. 

For the reasons stated in the 

preamble, the CSB revises 40 CFR part 

1601 to read as follows: 

PART 1601—PROCEDURES FOR 

DISCLOSURE OF RECORDS UNDER 

THE FREEDOM OF INFORMATION ACT 

Subpart A—Purpose, Scope, and 

Applicability 

Sec. 

1601.1 Purpose and scope. 

1601.2 Applicability. 

Subpart B—Procedures for Requesting and 

Disclosing Records 

1601.10 Proactive disclosures. 

1601.11 Requirements for making requests. 

1601.12 Responsibility for responding to 

requests. 

1601.13 Timing of responses to requests. 

1601.14 Responses to requests. 

1601.15 Special procedures for confidential 

commercial information. 

Subpart C—Appeals 

1601.20 Processing of appeals. 

Subpart D—Administration 

1601.30 Protection of records. 

1601.31 Preservation of records pertaining 

to requests under this part. 

1601.32 Other rights and services. 

Subpart E—Fees 

1601.40 Procedures for fees. 

Authority: 5 U.S.C. 552. 

Subpart A—Purpose, Scope, and 

Applicability 

§ 1601.1 Purpose and scope. 

(a) In general. This part contains the 

Chemical Safety and Hazard 

Investigation Board (‘‘CSB’’ or 

‘‘agency’’) regulations implementing the 

Freedom of Information Act (‘‘FOIA’’), 5 

U.S.C. 552. These regulations provide 

the procedures by which members of 

the public may obtain access to records 

compiled, created, and maintained by 

the CSB, along with the CSB procedures 

for responding to such requests. The 

rules in this subpart are to be read in 

conjunction with the FOIA and the 

Uniform Freedom of Information Fee 

Schedule and Guidelines published by 

the White House Office of Management 

and Budget (OMB Guidelines). 

(b) Definitions. 

(1) Chairperson means the 

Chairperson of the CSB. 

(2) Chief FOIA Officer means the 

person designated by Chairperson who 

has overall responsibility for the CSB’s 

compliance with the FOIA. 

(3) FOIA Officer means a person 

designated by the Chief FOIA Officer to 

process requests for the CSB documents 

under the FOIA. 

(4) Record means information 

regardless of its physical form or 

characteristics including information 

created, stored, and retrievable by 

electronic means that is created or 

obtained by the CSB and under the 

control of the CSB at the time of the 

request, including information 

maintained for the CSB by an entity 

under Government contract for records 

management purposes. Record includes 

any writing, drawing, map, recording, 

tape, film, photo, or other documentary 

material by which information is 

preserved. 

(5) Requester means any person, 

including an individual, Indian tribe, 

partnership, corporation, association, or 

public or private organization other than 

a Federal agency that requests access to 

records in the possession of the CSB 

pursuant to 5 U.S.C. 552. 

§ 1601.2 Applicability. 

(a) In general. The FOIA and the 

regulations in this part apply to all CSB 

documents and information. However, if 

another law sets specific procedures for 

disclosure that supersede the FOIA, 

then CSB must process a request in 

accordance with the procedures that 

apply to those specific documents. If a 

request is received for disclosure of a 

document to the public that is not 

required to be released under the 

provisions of law other than the FOIA, 

then the CSB must consider the request 

under the FOIA and the regulations in 

this part. Requests made by individuals 

for records about themselves under the 

Privacy Act of 1974, 5 U.S.C. 552a, are 

processed in accordance with CSB’s 

Privacy Act regulations (part 1602 of 

this chapter), as well as under this 

subpart. 

(b) Disclosure of requested records. 

The CSB will only withhold information 

under the FOIA if the agency reasonably 

foresees that disclosure would harm an 

interest protected by an exemption or 

disclosure is prohibited by law. The 

FOIA Officer will make requested 

records available to the public to the 

greatest extent possible in keeping with 

the FOIA, except for the following types 

of records, which are exempt from the 

disclosure requirements: 

(1) Records specifically authorized 

under criteria established by an 

Executive Order (E.O.) to be kept secret 

in the interest of national defense or 

foreign policy and which are, in fact, 

properly classified pursuant to such 

E.O.; 

(2) Records related solely to the 

internal personnel rules and practices of 

the CSB; 

(3) Records specifically exempted 

from disclosure by statute (other than 5 

U.S.C. 552(b)) provided that such statute 

requires that the matters be withheld 

from the public in such a manner as to 

leave no discretion on the issue or that 

the statute establishes particular criteria 

for withholding information or refers to 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45503 

particular types of matters to be 

withheld; and if enacted after the date 

of enactment of the OPEN FOIA Act of 

2009, specifically cites to 5 U.S.C. 

552(b)(3); 

(4) Records containing trade secrets 

and commercial or financial information 

obtained from a person and privileged 

or confidential; 

(5) Interagency or intra-agency 

memoranda or letters which would not 

be available by law to a party other than 

an agency in litigation with the CSB, 

provided that the deliberative process 

privilege shall not apply to records 

created twenty-five (25) years or more 

before the date on which the records 

were requested; 

(6) Personnel and medical files and 

similar files the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy; 

(7) Records or information 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 or any 

private institution which furnished 

information on a confidential basis, and 

in the case of a record or information 

compiled by criminal law enforcement 

authority in the course of a criminal 

investigation or by an agency 

conducting a lawful national security 

intelligence 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) Records contained in or related to 

examination, operating, or condition 

reports prepared by, or on behalf of, or 

for the use of an agency responsible for 

the regulation or supervision of 

financial institutions; 

(9) Geological or geophysical 

information and data, including maps, 

concerning wells. 

(c) Disclosure of segregable 

nonexempt material. The CSB will 

consider whether partial disclosure of 

information is possible whenever the 

agency determines that a full disclosure 

of a requested record is not possible. If 

a requested record contains exempted 

material along with nonexempted 

material, all reasonably segregable 

nonexempt material must be disclosed. 

(d) Records available through routine 

distribution procedures. If the record 

requested includes material published 

and offered for sale, e.g., by the 

Superintendent of Documents of the 

Government Printing Office, or by an 

authorized private distributor, then the 

CSB will refer the requester to those 

sources. Nevertheless, if the requester is 

not satisfied with the alternative 

sources, then the CSB will process the 

request under its usual FOIA 

procedures, noting that the CSB will 

likely withhold copyrighted records 

under Exemption 4. 

Subpart B—Procedures for Requesting 

and Disclosing Records 

§ 1601.10 Proactive disclosures. 

(a) In general. Records that the FOIA 

requires the CSB to make available for 

public inspection in an electronic 

format may be accessed through the 

CSB’s Web site (which can be found at 

http://www.csb.gov/disclaimers/legalaffairs-foia/). The CSB is responsible for 

determining which of its records must 

be made publicly available, for 

identifying additional records of interest 

to the public that are appropriate for 

public disclosure, and for posting and 

indexing such records. The CSB must 

ensure that its Web site of posted 

records and indices is reviewed and 

updated on an ongoing basis. The CSB 

has a FOIA Contact and FOIA Public 

Liaison who can assist individuals in 

locating records particular to the CSB. 

The most up to date contact information 

for the CSB’s FOIA Contact and the 

CSB’s FOIA Public Liaison is available 

at http://www.foia.gov/reportmakerequest.html. 

(b) Definitions. 

(1) Disclose or disclosure means 

making records available for 

examination or copying, or furnishing a 

copy of nonexempt responsive records. 

(2) FOIA Contact means the name, 

address and phone number at the CSB 

where a requester can make a FOIA 

request. 

(3) FOIA Public Liaison means the 

official who supervises the FOIA 

Requester Service Center. 

§ 1601.11 Requirements for making 

requests. 

(a) General information. (1) To make 

a request for records, a requester should 

write directly to the FOIA office of the 

agency that maintains the records 

sought. A request will receive the 

quickest possible response if the request 

is addressed to the FOIA office of the 

agency that maintains the records 

sought. If the CSB is the agency that 

maintains the records sought, then the 

contact information for the CSB’s FOIA 

office is listed at http://www.foia.gov/ 

report-makerequest.html, and any 

additional requirements for submitting a 

request can be found herein. 

Additionally, requesters who have 

questions or concerns about making a 

request, and those who have made a 

request who have questions or concerns, 

may discuss their request(s) with the 

CSB’s FOIA Contact or FOIA Public 

Liaison. 

(2) A requester who is making a 

request for records about himself or 

herself must comply with the 

verification of identity requirements 

described in this section. Requesters 

must provide either a notarized 

statement or a statement signed under 

penalty of perjury stating that the 

requester is the person they claim to be. 

This certification is required in order to 

protect the requester’s privacy and to 

ensure that private information about 

the requester is not disclosed 

inappropriately to another individual. 

(3) Where a request for records 

pertains to a third party, a requester may 

receive greater access by submitting 

either a notarized authorization signed 

by that individual or a declaration made 

in compliance with the requirements set 

forth in 28 U.S.C. 1746 by that 

individual authorizing disclosure of the 

records to the requester, or by 

submitting proof that the individual is 

deceased (e.g., a copy of a death 

certificate or an obituary). As an 

exercise of administrative discretion, 

the CSB can require a requester to 

supply additional information, if 

necessary, in order to verify that a 

particular individual has consented to 

disclosure. 

(b) Addressing requests. (1) All 

requests for records to the CSB must be 

made in writing. 

(2) For hard copy requests: The 

envelope and the request both should be 

clearly marked ‘‘FOIA Request’’ and 

addressed to: Chief FOIA Officer—FOIA 

Request, Chemical Safety and Hazard 

Investigation Board, 1750 Pennsylvania 

Ave. NW., Suite 910, Washington, DC 

20006. 

(3) For electronic requests: The 

subject line of the request should be 

marked ‘‘FOIA Request’’ and the request 

may be submitted by email to foia@

csb.gov. 

(4) A request that is improperly 

addressed will be deemed to have been 


asabaliauskas on DSKBBXCHB2PROD with RULES
45504 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

received by the CSB on the date that it 

is actually received by the CSB, or 

would have been received with the 

exercise of due diligence, by the FOIA 

Officer. 

(c) Description of records sought. (1) 

Requesters must describe the records 

sought in sufficient detail to enable the 

CSB’s personnel to locate them with a 

reasonable amount of effort. 

(2) To the extent possible, requesters 

should include specific information that 

may help the CSB identify the requested 

records, such as the date, title or name, 

author, recipient, subject matter of the 

record, case number, file designation, or 

reference number. In general, requesters 

should include as much detail as 

possible about the specific records or 

the types of records that they are 

seeking. Before submitting their 

requests, requesters may contact the 

CSB’s FOIA Contact or FOIA Public 

Liaison to discuss the records they seek 

and to receive assistance in describing 

the records. 

(3) If, after receiving a request, the 

CSB determines that the request does 

not reasonably describe the records 

sought, then the CSB must inform the 

requester what additional information is 

needed or why the request is otherwise 

insufficient. Requesters who are 

attempting to reformulate or modify 

such a request may discuss their request 

with the CSB’s FOIA Contact or with the 

CSB’s FOIA Public Liaison. If a request 

does not reasonably describe the records 

sought, the CSB’s response to the 

request may be delayed. 

(d) Form of records. Requests may 

specify the preferred form or format 

(including electronic formats) for the 

records that the requester seeks. The 

CSB must accommodate requests if the 

record is readily reproducible in that 

form or format. If a person seeks 

information from the CSB in a format 

that does not currently exist, then the 

CSB must make reasonable efforts to 

provide the information in the format 

requested. The CSB will not create a 

new record of information to satisfy a 

request. 

(e) Contact information. Requesters 

must provide their first and last name 

along with their contact information, 

such as their phone number, email 

address, and/or mailing address, to 

assist the CSB in communicating with 

them and providing released records. 

(f) Agreement to pay fees. The CSB 

considers a FOIA request an agreement 

by the requester to pay all applicable 

fees charged unless the requester seeks 

a waiver of fees. The CSB ordinarily will 

confirm this agreement in an 

acknowledgement letter. The CSB will 

not charge any fee if the total cost of the 

response is less than $25.00. See 

§ 1601.40 [discussing fees in more 

detail]. If the fee will be greater than 

$25.00, then the CSB must contact the 

requester to discuss how the requester 

wants to proceed. 

(g) Types of records not available. The 

FOIA does not require the CSB to: 

(1) Compile or create records solely 

for the purpose of satisfying a request 

for records; 

(2) Provide records not yet in 

existence, even if such records may be 

expected to come into existence at some 

future time; or 

(3) Restore records destroyed or 

otherwise disposed of, except that the 

FOIA Officer must notify the requester 

that the requested records have been 

destroyed or otherwise disposed of. 

§ 1601.12 Responsibility for responding to 

requests. 

(a) In general. The agency that first 

receives a request for a record and 

maintains that record is the agency 

responsible for responding to the 

request. In determining which records 

are responsive to a request, the CSB 

ordinarily will include only records in 

its possession as of the date that it 

begins its search. If any other date is 

used, the CSB must inform the requester 

of that date. A record that is excluded 

from the requirements of the FOIA 

pursuant to 5 U.S.C. 552(c), is not 

considered responsive to a request. 

(b) Authority to grant or deny 

requests. The Chief FOIA Officer or a 

designee is authorized to grant or to 

deny any initial request for records that 

are maintained by the CSB and to 

determine any appropriate fees. 

(c) Consultation, referral, and 

coordination. When reviewing records, 

the CSB must determine whether 

another agency of the Federal 

Government is better able to determine 

whether the record is exempt from 

disclosure under the FOIA. As to any 

such record, the CSB must proceed in 

one of the following ways: 

(1) Consultation. When records 

originated with the CSB, but contain 

within them information of interest to 

another agency or other Federal 

Government office, the CSB should 

consult with that other entity prior to 

making a release determination. 

(2) Referral. (i) When the CSB believes 

that a different agency or component of 

a different agency is best able to 

determine whether to disclose the 

record, the CSB should refer the 

responsibility for responding to the 

request regarding that record to that 

agency or component. Ordinarily, the 

agency that originated the record is 

presumed to be the best agency to make 

the disclosure determination. However, 

if the CSB and the originating agency 

jointly agree that the CSB is in the best 

position to respond regarding the 

record, then the record may be handled 

as a consultation. 

(ii) Whenever the CSB refers any part 

of the responsibility for responding to a 

request to another agency, it must 

document the referral, maintain a copy 

of the record that it refers, and notify the 

requester of the referral, informing the 

requester of the name(s) of the agency to 

which the record was referred, 

including that agency’s FOIA contact 

information. 

(3) Coordination. The standard 

referral procedure is not appropriate 

where disclosure of the identity of the 

agency to which the referral would be 

made could harm an interest protected 

by an applicable exemption, such as the 

exemptions that protect personal 

privacy or national security interests. 

For example, if a non-law enforcement 

agency responding to a request for 

records on a living third party locates 

within its files records originating with 

a law enforcement agency, and if the 

existence of that law enforcement 

interest in the third party was not 

publicly known, then to disclose that 

law enforcement interest could cause an 

unwarranted invasion of the personal 

privacy of the third party. Similarly, if 

an agency locates within its files 

material originating with an Intelligence 

Community agency, and the 

involvement of that agency in the matter 

is classified and not publicly 

acknowledged, then to disclose or give 

attribution to the involvement of that 

Intelligence Community agency could 

cause national security harms. In such 

instances, in order to avoid harm to an 

interest protected by an applicable 

exemption, the CSB must coordinate 

with the originating agency to seek its 

views on whether the record can be 

disclosed. The release determination for 

the record that is the subject of the 

coordination will then be conveyed to 

the requester by the CSB. 

(d) Classified information. Upon 

receipt of any request involving 

classified information, the CSB must 

determine whether the information is 

currently and properly classified in 

accordance with applicable 

classification rules. Whenever a request 

involves a record containing 

information that has been classified or 

may be appropriate for classification by 

another agency under any applicable 

E.O. concerning the classification of 

records, the CSB must refer the 

responsibility for responding to the 

request regarding that information to the 

agency that classified the information, 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45505 

or to the agency that should consider 

the information for classification. 

Whenever the CSB’s record contains 

information that has been derivatively 

classified (for example, when it contains 

information classified by another 

agency), the CSB must refer the 

responsibility for responding to that 

portion of the request to the agency that 

classified the underlying information. 

(e) Timing of responses to 

consultations and referrals. All 

consultations and referrals received by 

the CSB must be handled according to 

the date that the first agency received 

the perfected FOIA request. 

(f) Agreements regarding 

consultations and referrals. The CSB 

may establish agreements with other 

agencies to eliminate the need for 

consultations or referrals with respect to 

particular types of records. 

(g) No responsive record. If no records 

are responsive to the request, the FOIA 

Officer will so notify the requester in 

writing. 

§ 1601.13 Timing of responses to 

requests. 

(a) In general. The CSB ordinarily will 

respond to requests according to their 

order of receipt. 

(b) Definitions. 

(1) Working day means a Federal 

workday; Saturdays, Sundays, and 

Federal holidays are excluded in 

computing the response time for 

processing FOIA requests. 

(2) [Reserved] 

(c) Multitrack processing. The CSB 

has a specific track for requests that are 

granted expedited processing, in 

accordance with the standards set forth 

in paragraph (f) of this section. In 

addition, the CSB uses two standard 

processing tracks- one for simple 

requests and a separate track for 

complex requests. The CSB will assign 

requests to the simple or complex track 

based on the estimated amount of work 

or time needed to process the request. 

Among the factors the CSB may 

consider are the number of records 

requested, the number of pages involved 

in processing the request and the need 

for consultations or referrals. The CSB 

must advise each requester of the track 

into which their request falls and, when 

appropriate, will offer a requester an 

opportunity to narrow or modify their 

request so that it can be placed in the 

simple processing track. 

(d) Unusual circumstances. Whenever 

the CSB cannot meet the statutory time 

limit for processing a request because of 

‘‘unusual circumstances,’’ as defined in 

the FOIA, and the CSB extends the time 

limit on that basis, the CSB must, before 

expiration of the twenty (20) day period 

to respond, notify the requester in 

writing of the unusual circumstances 

involved and of the date by which the 

CSB estimates processing of the request 

will be completed. Where the extension 

exceeds ten (10) working days, the CSB 

must, as described by the FOIA, provide 

the requester with an opportunity to 

modify the request or arrange an 

alternative time period for processing 

the original or modified request. The 

CSB must make available its designated 

FOIA Contact or its FOIA Public Liaison 

for this purpose. A list of agency FOIA 

Public Liaisons is available at http://

www.foia.gov/report-makerequest.html. 

The CSB must also alert requesters to 

the availability of the Office of 

Government Information Services 

(OGIS) to provide dispute resolution 

services. 

(e) Aggregating requests. To satisfy 

unusual circumstances under the FOIA, 

the CSB may aggregate requests in cases 

where it reasonably appears that 

multiple requests, submitted either by a 

requester, or by a group of requesters 

acting in concert, constitute a single 

request that would otherwise involve 

unusual circumstances. The CSB must 

not aggregate multiple requests that 

involve unrelated matters. 

(f) Expedited processing. (1) The CSB 

must process requests and appeals on an 

expedited basis whenever it is 

determined that they involve: 

(i) Circumstances in which the lack of 

expedited processing could reasonably 

be expected to pose an imminent threat 

to the life or physical safety of an 

individual; 

(ii) An urgency to inform the public 

about an actual or alleged Federal 

Government activity, if made by a 

person who is primarily engaged in 

disseminating information; 

(iii) The loss of substantial due 

process rights; or 

(iv) A matter of widespread and 

exceptional media interest in which 

there exists possible questions about the 

government’s integrity that affect public 

confidence. 

(2) A request for expedited processing 

may be made at any time. Requests 

based on paragraphs (f)(1)(i) through (iv) 

of this section must be submitted to the 

CSB. When making a request for 

expedited processing of an 

administrative appeal, the request must 

be submitted to the CSB’s FOIA Appeals 

Officer in accordance with § 1601.20. 

(3) A requester who seeks expedited 

processing must submit a statement, 

certified to be true and correct, 

explaining in detail the basis for making 

the request for expedited processing. 

For example, under paragraph (f)(1)(ii) 

of this section, a requester who is not a 

full-time member of the news media 

must establish that the requester is a 

person whose primary professional 

activity or occupation is information 

dissemination, though it need not be the 

requester’s sole occupation. Such a 

requester also must establish a 

particular urgency to inform the public 

about the government activity involved 

in the request—one that extends beyond 

the public’s right to know about 

government activity generally. The 

existence of numerous articles 

published on a given subject can be 

helpful in establishing the requirement 

that there be an ‘‘urgency to inform’’ the 

public on the topic. As a matter of 

administrative discretion, the CSB may 

waive the formal certification 

requirement. 

(4) The CSB must notify the requester 

within ten (10) calendar days of the 

receipt of a request for expedited 

processing of its decision whether to 

grant or deny expedited processing. If 

expedited processing is granted, then 

the request must be given priority, 

placed in the processing track for 

expedited requests, and must be 

processed as soon as practicable. If a 

request for expedited processing is 

denied, then the CSB must act on any 

appeal of that decision expeditiously. 

§ 1601.14 Responses to requests. 

(a) In general. The CSB, to the extent 

practicable, will communicate 

electronically with requesters having 

access to the Internet, such as by email 

or web portal. 

(b) Acknowledgments of requests. The 

CSB must acknowledge the request in 

writing and assign it an individualized 

tracking number if it will take longer 

than ten (10) working days to process. 

The CSB must include in the 

acknowledgment a brief description of 

the records sought to allow requesters to 

more easily keep track of their requests. 

(c) Estimated dates of completion and 

interim responses. Upon request, the 

CSB must provide an estimated date by 

which the CSB expects to provide a 

response to the requester. If a request 

involves a voluminous amount of 

material, or searches in multiple 

locations, the CSB may provide interim 

responses, releasing the records on a 

rolling basis. 

(d) Grants of requests. Once the CSB 

determines it will grant a request in full 

or in part, it must notify the requester 

in writing. The notice must describe the 

manner in which the record or records 

will be disclosed, whether by providing 

a copy of the record or records with the 

response, or providing them at a later 

date, or by making a copy of the record 

available to the requester for inspection 


asabaliauskas on DSKBBXCHB2PROD with RULES
45506 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

at a reasonable time and place. The 

procedure for such an inspection must 

not unreasonably disrupt the operation 

of the CSB. The CSB must also inform 

the requester of any fees charged under 

§ 1601.40 and must disclose the 

requested records to the requester 

promptly upon payment of any 

applicable fees. The CSB must inform 

the requester of the availability of its 

FOIA Public Liaison to offer assistance. 

(e) Adverse determinations of 

requests. If the CSB makes an adverse 

determination denying a request in any 

respect, it must notify the requester of 

that determination in writing. Adverse 

determinations, or denials of requests, 

include decisions that: The requested 

record is exempt, in whole or in part; 

the request does not reasonably describe 

the records sought; the information 

requested is not a record subject to the 

FOIA; the requested record does not 

exist, cannot be located, or has been 

destroyed; or the requested record is not 

readily reproducible in the form or 

format sought by the requester. Adverse 

determinations also include denials 

involving fees or fee waiver matters or 

denials of requests for expedited 

processing. 

(f) Content of denial. The denial must 

be signed by the Chairperson or the 

FOIA Officer and must include: 

(1) The name and title or position of 

the person responsible for the denial; 

(2) A brief statement of the reasons for 

the denial, including any FOIA 

exemption(s) applied by the CSB in 

denying the request; 

(3) An estimate of the volume of any 

records or information withheld, such 

as the number of pages or some other 

reasonable form of estimation, although 

such an estimate is not required if the 

volume is otherwise indicated by 

deletions marked on records that are 

disclosed in part or if providing an 

estimate would harm an interest 

protected by an applicable exemption; 

and 

(4) A statement that the denial may be 

appealed under § 1601.20, and a 

description of the appeal requirements. 

(5) A statement notifying the requester 

of the assistance available from the 

CSB’s FOIA Public Liaison and the 

dispute resolution services offered by 

the OGIS. 

(g) Markings on released documents. 

Records disclosed in part must be 

marked clearly to show the amount of 

information deleted and the exemption 

under which the deletion was made 

unless doing so would harm an interest 

protected by an applicable exemption. 

The location of the information deleted 

must also be indicated on the record, if 

technically feasible. 

(h) Use of record exclusions. (1) In the 

event that the CSB identifies records 

that may be subject to exclusion from 

the requirements of the FOIA pursuant 

to 5 U.S.C. 552(c), the CSB must confer 

with Department of Justice, Office of 

Information Policy (OIP), to obtain 

approval to apply the exclusion. 

(2) When invoking an exclusion, the 

CSB must maintain an administrative 

record of the process of invocation and 

approval of the exclusion by OIP. 

§ 1601.15 Special procedures for 

confidential commercial information. 

(a) In general. Confidential 

commercial information provided to the 

CSB by a submitter must not be 

disclosed pursuant to a FOIA request 

except in accordance with this section. 

(b) Definitions. 

(1) Confidential commercial 

information means commercial or 

financial information obtained by the 

CSB from a submitter that may be 

protected from disclosure under 

Exemption 4 of the FOIA, 5 U.S.C. 

552(b)(4). 

(2) Submitter means any person or 

entity, including a corporation, State, or 

foreign government, Indian tribal 

governments but not including another 

Federal Government entity, that 

provides confidential commercial 

information, either directly or indirectly 

to the Federal Government. 

(c) Designation of confidential 

commercial information. A submitter of 

confidential commercial information 

must make good faith efforts to 

designate by appropriate markings, at 

the time of submission, any portion of 

its submission that it considers to be 

protected from disclosure under 

Exemption 4 of the FOIA, 5 U.S.C. 

552(b)(4). These designations expire ten 

(10) years after the date of the 

submission unless the submitter 

requests and provides justification for a 

longer designation period. 

(d) When notice to submitters is 

required. (1) The CSB must promptly 

provide written notice to the submitter 

of confidential commercial information 

whenever records containing such 

information are requested under the 

FOIA if the CSB determines that it may 

be required to disclose the records, 

provided: 

(i) The requested information has 

been designated in good faith by the 

submitter as information considered 

protected from disclosure under 

Exemption 4; or 

(ii) The CSB has a reason to believe 

that the requested information may be 

protected from disclosure under 

Exemption 4, but has not yet 

determined whether the information is 

protected from disclosure. 

(2) The notice must either describe 

the commercial information requested 

or include a copy of the requested 

records or portions of records 

containing the information. In cases 

involving a voluminous number of 

submitters, the CSB may post or publish 

a notice in a place or manner reasonably 

likely to inform the submitters of the 

proposed disclosure, instead of sending 

individual notifications. 

(e) Exceptions to submitter notice 

requirements. The notice requirements 

of this section do not apply if: 

(1) The CSB determines that the 

information is exempt under the FOIA, 

and therefore will not be disclosed; 

(2) The information has been lawfully 

published or has been officially made 

available to the public; 

(3) Disclosure of the information is 

required by a statute other than the 

FOIA or by a regulation issued in 

accordance with the requirements of 

E.O. 12600 of June 23, 1987; or 

(4) The designation made by the 

submitter under paragraph (c) of this 

section appears obviously frivolous. In 

such case, the CSB must give the 

submitter written notice of any final 

decision to disclose the information 

within a reasonable number of days 

prior to a specified disclosure date. 

(f) Opportunity to object to disclosure. 

(1) The CSB must specify a reasonable 

time period within which the submitter 

must respond to the notice referenced 

above. 

(2) If a submitter has any objections to 

disclosure, it should provide the CSB a 

detailed written statement that specifies 

all grounds for withholding the 

particular information under any 

exemption of the FOIA. In order to rely 

on Exemption 4 as basis for 

nondisclosure, the submitter must 

explain why the information constitutes 

a trade secret or commercial or financial 

information that is privileged or 

confidential. Whenever possible, the 

business submitter’s claim of 

confidentiality should be supported by 

a statement or certification by an officer 

or authorized representative of the 

business submitter. Information 

provided by a submitter pursuant to this 

paragraph may itself be subject to 

disclosure under the FOIA. 

(3) A submitter who fails to respond 

within the time period specified in the 

notice will be considered to have no 

objection to disclosure of the 

information. The CSB is not required to 

consider any information received after 

the date of any disclosure decision. Any 

information provided by a submitter 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45507 

under this subpart may itself be subject 

to disclosure under the FOIA. 

(g) Analysis of objections. The CSB 

must consider a submitter’s objections 

and specific grounds for nondisclosure 

in deciding whether to disclose the 

requested information. 

(h) Notice of intent to disclose. 

Whenever the CSB decides to disclose 

information over the objection of a 

submitter, the CSB must provide the 

submitter written notice, which must 

include: 

(1) A statement of the reasons why 

each of the submitter’s disclosure 

objections was not sustained; 

(2) A description of the information to 

be disclosed or copies of the records as 

the CSB intends to release them; and 

(3) A specified disclosure date, which 

must be a reasonable time after the 

notice. 

(i) Notice of FOIA lawsuit. Whenever 

a requester files a lawsuit seeking to 

compel the disclosure of confidential 

commercial information, the CSB must 

promptly notify the submitter. 

(j) Requester notification. The CSB 

must notify the requester whenever it 

provides the submitter with notice and 

an opportunity to object to disclosure 

because the request includes 

information that may arguably be 

exempt from disclosure under 

Exemption 4 of the FOIA; whenever it 

notifies the submitter of its intent to 

disclose the requested information; and 

whenever a submitter files a lawsuit to 

prevent the disclosure of the 

information. 

Subpart C—Appeals 

§ 1601.20 Processing of appeals. 

(a) Right of appeal. If a request has 

been denied in whole or in part, the 

requester may appeal the denial to the 

CSB’s FOIA Appeals Officer. 

(b) Definitions. 

(1) FOIA Appeal means an 

independent review of an adverse 

determination initial determination 

made in response to a FOIA request. 

(2) FOIA Appeals Officer means the 

person designated by the Chairperson to 

process and to decide a FOIA appeal. 

(c) Requirements for making an 

appeal. (1) A requester may appeal any 

adverse determinations to the FOIA 

Appeals Officer. Examples of adverse 

determinations are provided in 

§ 1601.14(e). 

(2) The requester must make the 

appeal in writing. Requesters can 

submit appeals by mail or email in 

accordance with the following 

requirements herein, which are also 

listed on the CSB’s Web site. To 

facilitate handling, the requester should 

mark both the appeal letter and 

envelope, or subject line of the 

electronic transmission, ‘‘Freedom of 

Information Act Appeal’’ or ‘‘FOIA 

Appeal.’’ 

(i) For hard copy requests: The 

envelope and the request both should 

addressed to: FOIA Appeals Officer— 

FOIA Appeal, Chemical Safety and 

Hazard Investigation Board, 1750 

Pennsylvania Ave. NW., Suite 910, 

Washington, DC 20006. 

(ii) For electronic requests: The 

appeal should addressed to the FOIA 

Appeals Officer and may be submitted 

by email to foiaappeals@csb.gov. 

(3) To be considered timely, an appeal 

must be postmarked, or in the case of 

electronic submissions, transmitted, 

within ninety (90) calendar days after 

the date of the adverse determination 

that is the subject of the appeal. For 

purposes of apply the ninety (90) 

calendar day deadline, the CSB will 

treat an appeal that is improperly 

addressed as being received on the date 

on the date that it is actually received 

by the CSB, or would have been 

received with the exercise of due 

diligence, by the FOIA Appeals Officer. 

(4) The appeal should clearly identify 

the adverse determination that is being 

appealed and the assigned request 

number. 

(5) An appeal should also include a 

copy of the initial request, a copy of the 

letter denying the request in whole or in 

part, and a statement of the 

circumstances, reasons, or arguments 

advanced in support of disclosure of the 

requested record. 

(d) Adjudication of appeals. (1) The 

CSB FOIA Appeals Officer or designee 

will act on behalf of the CSB’s Chief 

FOIA Officer on all appeals under this 

section. 

(2) An appeal ordinarily will not be 

adjudicated if the request becomes a 

matter of FOIA litigation. 

(3) On receipt of any appeal involving 

classified information, the FOIA 

Appeals Officer must take appropriate 

action to ensure compliance with 

applicable classification rules. 

(e) Decisions on appeals. The CSB 

must provide its decision on an appeal 

in writing. The disposition of an appeal 

will be in writing and will constitute the 

final action of the CSB on a request. A 

decision that upholds the CSB’s 

determination in whole or in part will 

contain a statement that identifies the 

reasons for the affirmance, including 

any FOIA exemptions applied. The 

decision will provide the requester with 

notification of the statutory right to file 

a lawsuit and will also inform the 

requester of the mediation services 

offered by the OGIS of the National 

Archives and Records Administration as 

a non-exclusive alternative to litigation. 

If the CSB’s decision is remanded or 

modified on appeal, the CSB must 

notify the requester of that 

determination in writing. The CSB must 

then further process the request in 

accordance with that appeal 

determination and will respond directly 

to the requester. 

(f) Engaging in dispute resolution 

services provided by OGIS. Dispute 

resolution is a voluntary process. If the 

CSB agrees to participate in the dispute 

resolution services provided by OGIS, it 

will actively engage as a partner to the 

process in an attempt to resolve the 

dispute. 

(g) When appeal is required. Before 

seeking review by a court of the CSB’s 

adverse determination, a requester 

generally must first submit a timely 

administrative appeal. 

Subpart D—Administration 

§ 1601.30 Protection of records. 

(a) In general. (1) Except as authorized 

by this part or as otherwise necessary in 

performing official duties, CSB 

employees must not disclose or permit 

disclosure of any document or 

information in the possession of the 

CSB that is confidential or otherwise of 

a nonpublic nature, including that 

regarding the CSB, the Environmental 

Protection Agency or the Occupational 

Safety and Health Administration. 

(2) No person may, without 

permission, remove from the place 

where it is made available any record 

made available to him for inspection or 

copying. Stealing, altering, mutilating, 

obliterating, or destroying a Federal 

record, in whole or in part, is a violation 

of Federal law. 

(b) [Reserved] 

§ 1601.31 Preservation of records 

pertaining to requests under this part. 

The CSB must preserve all 

correspondence pertaining to the 

requests that it receives under this 

subpart, as well as copies of all 

requested records, until disposition or 

destruction is authorized pursuant to 

title 44 of the United States Code and 

the General Records Schedule 4.2 of the 

National Archives and Records 

Administration. The CSB must not 

dispose of or destroy records while they 

are the subject of a pending request, 

appeal, or lawsuit under the FOIA. 

§ 1601.32 Other rights and services. 

Nothing in this subpart will be 

construed to entitle any person, as of 

right, to any service or to the disclosure 

of any record to which such person is 

not entitled under the FOIA. 


asabaliauskas on DSKBBXCHB2PROD with RULES
45508 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

Subpart E—Fees 

§ 1601.40 Procedures for fees. 

(a) In general. The CSB must charge 

for processing requests under the FOIA 

in accordance with the provisions of 

this section and with the OMB 

Guidelines. For purposes of assessing 

fees, the FOIA establishes three 

categories of requesters: Commercial use 

requesters, non-commercial scientific or 

educational institutions or news media 

requesters, and all other requesters. 

Different fees are assessed depending on 

the category. Requesters may seek a fee 

waiver. The CSB must consider requests 

for fee waivers in accordance with the 

requirements in paragraph (k) of this 

section. To resolve any fee issues that 

arise under this section, the CSB may 

contact a requester for additional 

information. The CSB must ensure that 

searches, review, and duplication are 

conducted in the most efficient and the 

least expensive manner. The CSB 

ordinarily will collect all applicable fees 

before sending copies of records to a 

requester. Requesters must pay fees by 

check or money order made payable to 

the Treasury of the United States, or by 

another method as determined by the 

CSB. 

(b) Definitions. 

(1) Commercial use request is a 

request that asks for information for a 

use or a purpose that furthers a 

commercial, trade, or profit interest, 

which can include furthering those 

interests through litigation. The CSB’s 

decision to place a requester in the 

commercial use category will be made 

on a case-by-case basis based on the 

requester’s intended use of the 

information. The CSB must notify 

requesters of their placement in this 

category. 

(2) Direct costs are those expenses that 

the CSB incurs in searching for and 

duplicating (and, in the case of 

commercial use requests, reviewing) 

records in order to respond to a FOIA 

request. For example, direct costs 

include the salary of the employee 

performing the work (i.e., the basic rate 

of pay for the employee, plus sixteen 

percent (16%) of that rate to cover 

benefits) and the cost of operating 

computers and other electronic 

equipment, such as photocopiers and 

scanners. Direct costs do not include 

overhead expenses such as the costs of 

space, and of heating or lighting a 

facility. 

(3) Duplication is reproducing a copy 

of a record, or of the information 

contained in it, necessary to respond to 

a FOIA request. Copies can take the 

form of paper, audiovisual materials, or 

electronic records, among others. The 

copies provided must be in a form that 

is reasonably usable by requesters. 

(4) Educational institution is any 

school that operates a program of 

scholarly research. A requester in this 

fee category must show that the request 

is made in connection with the 

requester’s role at the educational 

institution. The CSB may seek 

verification from the requester that the 

request is in furtherance of scholarly 

research and the CSB must advise 

requesters of their placement in this 

category. 

(i) Example 1. A request from a 

professor of geology at a university for 

records relating to soil erosion, written 

on letterhead of the Department of 

Geology, would be presumed to be from 

an educational institution. 

(ii) Example 2. A request from the 

same professor of geology seeking drug 

information from the Food and Drug 

Administration in furtherance of a 

murder mystery he is writing would not 

be presumed to be an institutional 

request, regardless of whether it was 

written on institutional stationery. 

(iii) Example 3. A student who makes 

a request in furtherance of the student’s 

coursework or other school-sponsored 

activities and provides a copy of a 

course syllabus or other reasonable 

documentation to indicate the research 

purpose for the request, would qualify 

as part of this fee category. 

(5) Noncommercial scientific 

institution is an institution that is not 

operated on a ‘‘commercial’’ basis, as 

defined in paragraph (b)(1) of this 

section and that is operated solely for 

the purpose of conducting scientific 

research the results of which are not 

intended to promote any particular 

product or industry. A requester in this 

category must show that the request is 

authorized by and is made under the 

auspices of a qualifying institution and 

that the records are sought to further 

scientific research and are not for a 

commercial use. The CSB must advise 

requesters of their placement in this 

category. 

(6) Representative of the news media 

is any person or entity that gathers 

information of potential interest to a 

segment of the public, uses its editorial 

skills to turn the raw materials into a 

distinct work, and distributes that work 

to an audience. Accordingly, the term 

includes 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. Examples of news media 

entities include television or radio 

stations that broadcast news to the 

public at large, and publishers of 

periodicals that disseminate news and 

make their products available through a 

variety of means to the general public, 

including news organizations that make 

their products available for purchase by 

or subscription by or free distribution to 

the general public, including those 

solely on the Internet. These examples 

are not all-inclusive. Moreover, as 

methods of news delivery evolve (for 

example, the adoption of the electronic 

dissemination of newspapers through 

telecommunications services), such 

alternative media shall be considered to 

be news-media entities. A request for 

records supporting the newsdissemination function of the requester 

will not be considered to be for a 

commercial use. Freelance journalists 

who demonstrate a solid basis for 

expecting publication through a news 

media entity will be considered as a 

representative of the news media. A 

publishing contract would provide the 

clearest evidence that publication is 

expected; however, the CSB can also 

consider a requester’s past publication 

record in making this determination. 

The CSB will advise requesters of their 

placement in this category. 

(7) Review is the examination of a 

record located in response to a FOIA 

request in order to determine whether 

any portion of it is exempt from 

disclosure under one or more of the 

FOIA exemptions. Review time includes 

processing any record for disclosure, 

such as doing all that is necessary to 

prepare the record for disclosure, 

including the process of redacting the 

record and marking the appropriate 

exemptions. Review costs are properly 

charged even if a record ultimately is 

not disclosed. Review time also 

includes time spent both obtaining and 

considering any formal objection to 

disclosure made by a confidential 

commercial information submitter 

under § 1601.15, but it does not include 

time spent resolving general legal or 

policy issues regarding the application 

of exemptions. 

(8) Search is the process of looking for 

and retrieving records or information 

responsive to a request. Search time 

includes page-by-page or line-by-line 

identification of information within 

records and the reasonable efforts 

expended to locate and retrieve 

information from electronic records. 

(c) Charging fees. In responding to 

FOIA requests, the CSB will charge the 

following fees unless a waiver or 

reduction of fees has been granted under 

paragraph (k) of this section. Because 

the fee amounts provided below already 

account for the direct costs associated 

with a given fee type, the CSB should 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45509 

not add any additional costs to charges 

calculated under this section. 

(1) Search. (i) Requests made by 

educational institutions, noncommercial 

scientific institutions, or representatives 

of the news media are not subject to 

search fees. The CSB must charge search 

fees for all other requesters, subject to 

the restrictions of paragraph (d) of this 

section. The CSB may properly charge 

for time spent searching even if they do 

not locate any responsive records or if 

they determine that the records are 

entirely exempt from disclosure. 

(ii) For each quarter hour spent by 

personnel searching for requested 

records, including electronic searches 

that do not require new programming, 

the fees will be charged as follows: 

$6.00 for clerical personnel; $11.00 for 

professional personnel; and $15.00 for 

managerial personnel. 

(iii) The CSB must charge the direct 

costs associated with conducting any 

search that requires the creation of a 

new computer program to locate the 

requested records. The CSB must notify 

the requester of the costs associated 

with creating such a program, and the 

requester must agree to pay the 

associated costs before the costs may be 

incurred. 

(iv) For requests that require the 

retrieval of records stored by the CSB at 

a Federal records center operated by the 

National Archives and Records 

Administration (NARA), the CSB must 

charge additional costs in accordance 

with the Transactional Billing Rate 

Schedule established by NARA. 

(2) Duplication. The CSB will charge 

duplication fees to all requesters, 

subject to the restrictions of paragraph 

(d) of this section. The CSB must honor 

a requester’s preference for receiving a 

record in a particular form or format 

where the CSB can readily reproduce it 

in the form or format requested. Where 

photocopies are supplied, the CSB must 

provide one copy per request at the cost 

of $0.17 per page. For copies of records 

produced on tapes, disks, or other 

media, the CSB must charge the direct 

costs of producing the copy, including 

operator time. Where paper documents 

must be scanned in order to comply 

with a requester’s preference to receive 

the records in an electronic format, the 

requester must also pay the direct costs 

associated with scanning those 

materials. For other forms of 

duplication, the CSB must charge the 

direct costs. 

(3) Review. The CSB must charge 

review fees to requesters who make 

commercial use requests. Review fees 

will be assessed in connection with the 

initial review of the record, i.e., the 

review conducted by the CSB to 

determine whether an exemption 

applies to a particular record or portion 

of a record. No charge will be made for 

review at the administrative appeal 

stage of exemptions applied at the 

initial review stage. However, if a 

particular exemption is deemed to no 

longer apply, any costs associated with 

the CSB’s re-review of the records in 

order to consider the use of other 

exemptions may be assessed as review 

fees. Review fees will be charged at the 

same rates as those charged for a search 

under paragraph (c)(1)(ii) of this section. 

(d) Restrictions on charging fees. (1) 

When the CSB determines that a 

requester is an educational institution, 

non-commercial scientific institution, or 

representative of the news media, and 

the records are not sought for 

commercial use, it will not charge 

search fees. 

(2)(i) If the CSB fails to comply with 

the FOIA’s time limits in which to 

respond to a request, it may not charge 

search fees, or, in the instances of 

requests from requesters described in 

paragraph (d)(1) of this section, may not 

charge duplication fees, except as 

described in paragraphs (d)(2)(ii)–(iv). 

(ii) If the CSB has determined that 

unusual circumstances as defined by the 

FOIA apply and the CSB provided 

timely written notice to the requester in 

accordance with the FOIA, a failure to 

comply with the time limit must be 

excused for an additional ten (10) days. 

(iii) If the CSB has determined that 

unusual circumstances as defined by the 

FOIA apply, and more than 5,000 pages 

are necessary to respond to the request, 

the CSB may charge search fees, or, in 

the case of requesters described in 

paragraph (d)(1) of this section, may 

charge duplication fees, if the following 

steps are taken. The CSB must have 

provided timely written notice of 

unusual circumstances to the requester 

in accordance with the FOIA and the 

CSB must have discussed with the 

requester via written mail, email, or 

telephone (or made not less than three 

good-faith attempts to do so) how the 

requester could effectively limit the 

scope of the request in accordance with 

5 U.S.C. 552(a)(6)(B)(ii). If this 

exception is satisfied, the CSB may 

charge all applicable fees incurred in 

the processing of the request. 

(iv) If a court has determined that 

exceptional circumstances exist as 

defined by the FOIA, a failure to comply 

with the time limits shall be excused for 

the length of time provided by the court 

order. 

(3) No search or review fees will be 

charged for a quarter-hour period unless 

more than half of that period is required 

for search or review. 

(4) Except for requesters seeking 

records for a commercial use, the CSB 

must provide without charge: 

(i) The first 100 pages of duplication 

(or the cost equivalent for other media); 

and 

(ii) The first two hours of search. 

(5) No fee will be charged when the 

total fee, after deducting the 100 free 

pages (or its cost equivalent) and the 

first two hours of search, is equal to or 

less than $25.00. 

(e) Notice of anticipated fees in excess 

of $25.00. (1) When the CSB determines 

or estimates that the fees to be assessed 

in accordance with this section will 

exceed $25.00, the CSB must notify the 

requester of the actual or estimated 

amount of the fees, including a 

breakdown of the fees for search, review 

or duplication, unless the requester has 

indicated a willingness to pay fees as 

high as those anticipated. If only a 

portion of the fee can be estimated 

readily, the CSB must advise the 

requester accordingly. If the request is 

for non-commercial use, the notice will 

specify that the requester is entitled to 

the statutory entitlements of 100 pages 

of duplication at no charge and, if the 

requester is charged search fees, two 

hours of search time at no charge, and 

will advise the requester whether those 

entitlements have been provided. 

(2) If the CSB notifies the requester 

that the actual or estimated fees are in 

excess of $25.00, the request will not be 

considered received and further work 

will not be completed until the 

requester commits in writing to pay the 

actual or estimated total fee, or 

designates some amount of fees the 

requester is willing to pay, or in the case 

of a non-commercial use requester who 

has not yet been provided with the 

requester’s statutory entitlements, 

designates that the requester seeks only 

that which can be provided by the 

statutory entitlements. The requester 

must provide the commitment or 

designation in writing, and must, when 

applicable, designate an exact dollar 

amount the requester is willing to pay. 

The CSB is not required to accept 

payments in installments. Requesters 

must respond to their fee estimate 

within thirty (30) working days, or the 

CSB will assume that the requester is no 

longer interested in their FOIA 

request(s), and the case will be 

administratively closed. 

(3) If the requester has indicated a 

willingness to pay some designated 

amount of fees, but the CSB estimates 

that the total fee will exceed that 

amount, the CSB will toll the processing 

of the request when it notifies the 

requester of the estimated fees in excess 

of the amount the requester has 


asabaliauskas on DSKBBXCHB2PROD with RULES
45510 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

indicated a willingness to pay. The CSB 

will inquire whether the requester 

wishes to revise the amount of fees the 

requester is willing to pay or modify the 

request. Once the requester responds, 

the time to respond will resume from 

where it was at the date of the 

notification. 

(4) The CSB must make available its 

FOIA Public Liaison or anther FOIA 

professional to assist any requester in 

reformulating a request to meet the 

requester’s needs at a lower cost. 

(f) Charges for other services. 

Although not required to provide 

special services, if the CSB chooses to 

do so as a matter of administrative 

discretion, the direct costs of providing 

the service will be charged. Examples of 

such services include certifying that 

records are true copies, providing 

multiple copies of the same document, 

or sending records by means other than 

first class mail. 

(g) Charging interest. The CSB may 

charge interest on any unpaid bill 

starting on the thirty-first (31) day 

following the date of billing the 

requester. Interest charges will be 

assessed at the rate provided in 31 

U.S.C. 3717 and will accrue from the 

billing date until payment is received by 

the CSB. The CSB must follow the 

provisions of the Debt Collection Act of 

1982 (Pub. L. 97–365, 96 Stat. 1749), as 

amended, and its administrative 

procedures, including the use of 

consumer reporting agencies, collection 

agencies, and offset. 

(h) Aggregating requests. When the 

CSB reasonably believes that a requester 

or a group of requesters acting in 

concert is attempting to divide a single 

request into a series of requests for the 

purpose of avoiding fees, the CSB may 

aggregate those requests and charge 

accordingly. The CSB may presume that 

multiple requests of this type made 

within a thirty (30) day period have 

been made in order to avoid fees. For 

requests separated by a longer period, 

the CSB must aggregate them only 

where there is a reasonable basis for 

determining that aggregation is 

warranted in view of all the 

circumstances involved. Multiple 

requests involving unrelated matters 

cannot be aggregated. 

(i) Advance payments. (1) For 

requests other than those described in 

paragraphs (i)(2) or (i)(3) of this section, 

the CSB must not require the requester 

to make an advance payment before 

work is commenced or continued on a 

request. Payment owed for work already 

completed (i.e., payment before copies 

are sent to a requester) is not an advance 

payment. 

(2) When the CSB determines or 

estimates that a total fee to be charged 

under this section will exceed $250.00, 

it may require that the requester make 

an advance payment up to the amount 

of the entire anticipated fee before 

beginning to process the request. The 

CSB may elect to process the request 

prior to collecting fees when it receives 

a satisfactory assurance of full payment 

from a requester with a history of 

prompt payment. 

(3) Where a requester has previously 

failed to pay a properly charged FOIA 

fee to the CSB within thirty (30) 

calendar days of the billing date, the 

CSB may require that the requester pay 

the full amount due, plus any applicable 

interest on that prior request, and the 

CSB may require that the requester 

make an advance payment of the full 

amount of any anticipated fee before the 

CSB begins to process a new request or 

continues to process a pending request 

or any pending appeal. Where the CSB 

has a reasonable basis to believe that a 

requester has misrepresented the 

requester’s identity in order to avoid 

paying outstanding fees, it may require 

that the requester provide proof of 

identity. 

(4) In cases in which the CSB requires 

advance payment, the request will not 

be considered received and further work 

will not be completed until the required 

payment is received. If the requester 

does not pay the advance payment 

within thirty (30) calendar days after the 

date of the CSB’s fee determination, the 

request will be closed. 

(j) Other statutes specifically 

providing for fees. The fee schedule of 

this section does not apply to fees 

charged under any statute that 

specifically requires the CSB to set and 

collect fees for particular types of 

records. In instances where records 

responsive to a request are subject to a 

statutorily-based fee schedule program, 

the CSB must inform the requester of 

the contact information for that 

program. 

(k) Requirements for waiver or 

reduction of fees. (1) Requesters may 

seek a waiver of fees by submitting a 

written application demonstrating how 

disclosure of the requested information 

is in the public interest because it is 

likely to contribute significantly to 

public understanding of the operations 

or activities of the government and is 

not primarily in the commercial interest 

of the requester. 

(2) The CSB must furnish records 

responsive to a request without charge 

or at a reduced rate when it determines, 

based on all available information, that 

disclosure of the requested information 

is in the public interest because it is 

likely to contribute significantly to 

public understanding of the operations 

or activities of the government and is 

not primarily in the commercial interest 

of the requester. In deciding whether 

this standard is satisfied the CSB must 

consider the factors described in 

paragraphs (k)(2)(i) through (iii) of this 

section: 

(i) Disclosure of the requested 

information would shed light on the 

operations or activities of the 

government. The subject of the request 

must concern identifiable operations or 

activities of the Federal Government 

with a connection that is direct and 

clear, not remote or attenuated. 

(ii) Disclosure of the requested 

information is likely to contribute 

significantly to public understanding of 

those operations or activities. This 

factor is satisfied when the following 

criteria are met: 

(A) Disclosure of the requested 

records must be meaningfully 

informative about government 

operations or activities. The disclosure 

of information that already is in the 

public domain, in either the same or a 

substantially identical form, would not 

be meaningfully informative if nothing 

new would be added to the public’s 

understanding. 

(B) The disclosure must contribute to 

the understanding of a reasonably broad 

audience of persons interested in the 

subject, as opposed to the individual 

understanding of the requester. A 

requester’s expertise in the subject area 

as well as the requester’s ability and 

intention to effectively convey 

information to the public must be 

considered. The CSB will presume that 

a representative of the news media will 

satisfy this consideration. 

(iii) The disclosure must not be 

primarily in the commercial interest of 

the requester. To determine whether 

disclosure of the requested information 

is primarily in the commercial interest 

of the requester, the CSB must consider 

the following criteria: 

(A) The CSB must identify whether 

the requester has any commercial 

interest that would be furthered by the 

requested disclosure. A commercial 

interest includes any commercial, trade, 

or profit interest. Requesters must be 

given an opportunity to provide 

explanatory information regarding this 

consideration. 

(B) If there is an identified 

commercial interest, the CSB must 

determine whether that is the primary 

interest furthered by the request. A 

waiver or reduction of fees is justified 

when the requirements of paragraphs 

(k)(2)(i) and (ii) are satisfied and any 

commercial interest is not the primary 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45511 

1See: https://www.whitehouse.gov/the-pressoffice/2017/01/20/memorandum-heads-executivedepartments-and-agencies. 

interest furthered by the request. The 

CSB ordinarily will presume that when 

a news media requester has satisfied the 

factors in paragraphs (k)(2)(i) and (ii) of 

this section, the request is not primarily 

in the commercial interest of the 

requester. Disclosure to data brokers or 

others who merely compile and market 

government information for direct 

economic return will not be presumed 

to primarily serve the public interest. 

(3) Where only some of the records to 

be released satisfy the requirements for 

a waiver of fees, a waiver must be 

granted for those records. 

(4) Requests for a waiver or reduction 

of fees should be made when the request 

is first submitted to the CSB and should 

address the criteria referenced above. A 

requester may submit a fee waiver 

request at a later time so long as the 

underlying record request is pending or 

on administrative appeal. When a 

requester who has committed to pay 

fees subsequently asks for a waiver of 

those fees and that waiver is denied, the 

requester must pay any costs incurred 

up to the date the fee waiver request 

was received. 

Dated: September 25, 2017 

Kara Wenzel, 

Acting General Counsel, Chemical Safety and 

Hazard Investigation Board. 

[FR Doc. 2017–20853 Filed 9–28–17; 8:45 am] 

BILLING CODE 6350–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 10 

RIN 0906–AB11 

340B Drug Pricing Program Ceiling 

Price and Manufacturer Civil Monetary 

Penalties Regulation 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Final rule; further delay of 

effective date. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

administers section 340B of the Public 

Health Service Act (PHSA), known as 

the ‘‘340B Drug Pricing Program’’ or the 

‘‘340B Program.’’ HRSA published a 

final rule on January 5, 2017, that set 

forth the calculation of the ceiling price 

and application of civil monetary 

penalties. The final rule applied to all 

drug manufacturers that are required to 

make their drugs available to covered 

entities under the 340B Program. On 

August 21, 2017, HHS solicited 

comments on further delaying the 

effective date of the January 5, 2017, 

final rule to July 1, 2018 (82 FR 39553). 

HHS proposed this action to allow a 

more deliberate process of considering 

alternative and supplemental regulatory 

provisions and to allow for sufficient 

time for additional rulemaking. After 

consideration of the comments received 

on the proposed rule, HHS is delaying 

the effective date of the January 5, 2017, 

final rule, to July 1, 2018. 

DATES: As of September 29, 2017, the 

effective date of the final rule published 

in the Federal Register (82 FR 1210, 

January 5, 2017) is further delayed to 

July 1, 2018. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Krista Pedley, Director, Office of 

Pharmacy Affairs, Healthcare Systems 

Bureau, HRSA, 5600 Fishers Lane, Mail 

Stop 08W05A, Rockville, MD 20857, or 

by telephone at 301–594–4353. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On September 30, 2010, HHS 

published an advanced notice of 

proposed rulemaking (ANPRM) in the 

Federal Register, ‘‘340B Drug Pricing 

Program Manufacturer Civil Monetary 

Penalties’’ (75 FR 57230, September 20, 

2010). HHS subsequently published a 

notice of proposed rulemaking (NPRM) 

on June 17, 2015, to implement CMPs 

for manufacturers that knowingly and 

intentionally charge a covered entity 

more than the ceiling price for a covered 

outpatient drug; to provide clarity 

regarding the requirement that 

manufacturers calculate the 340B 

ceiling price on a quarterly basis; and to 

establish the requirement that a 

manufacturer charge $.01 (penny 

pricing) for drugs when the ceiling price 

calculation equals zero (80 FR 34583, 

June 17, 2015). The public comment 

period closed on August 17, 2015, and 

HRSA received 35 comments. After 

review of the initial comments, HHS 

reopened the comment period (81 FR 

22960, April 19, 2016) to invite 

additional comments on the following 

areas of the NPRM: 340B ceiling price 

calculations that result in a ceiling price 

that equals zero (penny pricing); the 

methodology that manufacturers use 

when estimating the ceiling price for a 

new covered outpatient drug; and the 

definition of the ‘‘knowing and 

intentional’’ standard to be applied 

when assessing a CMP for 

manufacturers that overcharge a covered 

entity. The comment period closed May 

19, 2016, and HHS received 72 

comments. 

On January 5, 2017, HHS published a 

final rule in the Federal Register (82 FR 

1210, January 5, 2017); comments from 

both the original comment period 

established in the NPRM and the 

reopened comment period announced 

in the April 19, 2016 notice were 

considered in the development of the 

final rule. The provisions of that final 

rule were to be effective March 6, 2017; 

however, HHS issued a subsequent final 

rule (82 FR 12508, March 6, 2017) 

delaying the effective date to March 21, 

2017, in accordance with a January 20, 

2017, memorandum from the Assistant 

to the President and Chief of Staff, titled 

‘‘Regulatory Freeze Pending Review.’’ 1

In the January 5, 2017, final rule, HHS 

acknowledged that the effective date fell 

during the middle of a quarter and 

stakeholders needed time to adjust 

systems and update their policies and 

procedures. As such, HHS stated that it 

intended to enforce the requirements of 

the final rule at the start of the next 

quarter, which began April 1, 2017. 

After further consideration and to 

provide affected parties sufficient time 

to make needed changes to facilitate 

compliance, and because questions were 

raised, HHS issued an interim final rule 

(82 FR 14332, March 20, 2017), to delay 

the effective date of the final rule to May 

22, 2017, and solicited additional 

comments on whether that date should 

be further extended to October 1, 2017. 

HHS received 51 comments on the 

interim final rule, some supporting and 

some opposing the delay of the effective 

date to May 22, 2017, or alternatively to 

October 1, 2017. After careful 

consideration of the comments received, 

HHS delayed the effective date of the 

January 5, 2017, final rule to October 1, 

2017 (82 FR 22893, May 19, 2017). 

HHS subsequently published a 

proposed rule (82 FR 39553, August 21, 

2017) to further delay the effective date 

of the final rule to July 1, 2018. The 

further delay allows necessary time to 

fully consider the substantial questions 

of fact, law, and policy raised by the 

rule, consistent with the aforementioned 

‘‘Regulatory Freeze Pending Review,’’ 

memorandum. Requiring manufacturers 

to make targeted and potentially costly 

changes to pricing systems and business 

procedures in order to comply with a 

rule that is under further consideration 

and for which substantive questions 

have been raised would be disruptive. 

The further delay allows HHS to 

consider objections regarding the timing 

of the effective date and challenges 

associated with complying with the 

rule, as well as other objections to the 

rule. 

In addition, Executive Order 13765 

(82 FR 8351) titled, ‘‘Minimizing the 


asabaliauskas on DSKBBXCHB2PROD with RULES