Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 46437 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.11B, 

Airspace Designations and Reporting 

Points, dated August 3, 2017, and 

effective September 15, 2017, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward from 700 feet or More 

Above the Surface of the Earth. 

* * * * * 

AAL AK E5 Badami, AK [Amended] 

Badami, Badami Airport, AK 

(Lat. 70°08′15′′ N, long. 147°01′50′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of Badami Airport, AK; and that 

airspace extending upward from 1,200 feet 

above the surface within a 73-mile radius of 

Badami Airport, AK, excluding that airspace 

extending beyond 12 miles of the shoreline. 

Issued in Seattle, Washington, on 

September 5, 2018. 

Shawn M. Kozica, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2018–19728 Filed 9–12–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 20 and 720 

[Docket No. FDA–2018–N–1622] 

RIN 0910–AH69 

Public Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

proposing to amend its public 

information regulations. The proposed 

rule will revise the current regulations 

to incorporate changes made to the 

Freedom of Information Act (FOIA) by 

the Openness Promotes Effectiveness in 

our National Government Act of 2007 

(OPEN Government Act) and the FOIA 

Improvement Act of 2016 (FOIA 

Improvement Act). Additionally, the 

proposed rule will update the current 

regulations to reflect changes to the 

organization, to make the FOIA process 

easier for the public to navigate, and to 

make provisions clearer. 

DATES: Submit either electronic or 

written comments on this proposed rule 

by November 13, 2018. See section VI of 

this document for the proposed effective 

date of a final rule based on this 

document. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: • Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. • If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public submit the comment as a written/ 

paper submission and in the manner 

detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions.’’) 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: • Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–1622 for ‘‘Public Information; 

Proposed Rule.’’ Received comments, 

those received in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sarah B. Kotler, Office of the 

Commissioner, Office of the Executive 

Secretariat, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1050, Rockville, MD 20857, 301–796– 

3900, FDAFOIA@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 


daltland on DSKBBV9HB2PROD with PROPOSALS
46438 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations and Acronyms 

Commonly Used Acronyms in This 

Document 

III. Background 

IV. Legal Authority 

V. Description of the Proposed Rule 

VI. Proposed Effective Date 

VII. Economic Analysis of Impacts 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination with 

Indian Tribal Governments 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA is proposing to amend FDA’s 

public information regulations. The 

regulations are being amended to 

incorporate changes made to FOIA by 

the OPEN Government Act (Pub. L. 89– 

487) and the FOIA Improvement Act 

(Pub. L. 114–185). Additionally, the 

proposed rule will update the 

regulations to reflect changes to the 

organization, to make the FOIA process 

easier for the public to navigate, and to 

make certain provisions clearer. Taken 

together, these changes will enhance 

transparency for the public with regard 

to FDA activities. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed amendments to FDA’s 

public information regulations bring the 

Agency’s regulations in line with 

statutory amendments to the FOIA, 

update cross references to other statutes 

and parts of the Agency’s regulations, 

and clarify certain provisions with 

minor editorial updates. 

C. Legal Authority 

We are proposing these amendments 

based on our authority under FOIA (5 

U.S.C. 552) and section 701(a) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 371(a)). These 

proposed amendments would allow 

FDA to more efficiently use our 

resources to provide information to the 

public. 

D. Costs and Benefits 

Although FDA is currently 

implementing the requirements of the 

OPEN Government Act and the FOIA 

Improvement Act in FOIA processing as 

standard practice, the requirements are 

not currently reflected in part 20 (21 

CFR part 20). The revisions made by 

this proposed rule are intended to 

incorporate all current FOIA 

requirements into the existing 

regulations. Because the Agency has 

already adopted many of these 

requirements, we anticipate no 

additional costs or benefits from this 

rulemaking. 

II. Table of Abbreviations and 

Acronyms Commonly Used in This 

Document 

Abbreviation/ 

Acronym What it means 

DFOI .............. Division of Freedom of Information. 

FOIA ............... Freedom of Information Act. 

FOIA Improvement Act.FOIA Improvement Act of 

2016. 

OGIS .............. Office of Government Information Services. 

OPEN Government Act.Openness Promotes Effectiveness in our National 

Government Act of 2007. 

III. Background 

The FOIA is a law that gives the 

public the right to access information 

from the Federal government. There is 

a presumption that government records 

must be released under FOIA unless 

they are subject to one of nine FOIA 

exemptions. FDA’s regulations for the 

implementation of the FOIA are in part 

20. The FOIA Improvement Act 

specifically requires Agencies to review 

their FOIA regulations and update their 

regulations for the disclosure of records 

in accordance with its amendments. 

IV. Legal Authority 

We are proposing these amendments 

based on our authority under FOIA (5 

U.S.C. 552) and section 701(a) of the 

FD&C Act (21 U.S.C. 371(a)). These 

proposed amendments would allow 

FDA to more efficiently use our 

resources to provide information to the 

public. 

V. Description of the Proposed Rule 

We are proposing to amend 

provisions of part 20 regarding the 

Agency’s public information 

regulations. Once effective, the 

amendments contained in the proposed 

rule would apply to all FOIA requests 

currently pending with, or received in 

the future by, FDA. 

• The proposed amendments to 

§ 20.20 would require FDA to withhold 

information under the FOIA only if the 

Agency reasonably foresees that 

disclosure would harm an interest 

protected by an exemption or disclosure 

is prohibited by law. The proposed rule 

further amends this provision to require 

FDA to establish procedures for 

identifying records of general interest or 

use to the public that are appropriate for 

public disclosure, and for posting such 

records in a publicly accessible 

electronic format. These changes will 

promote transparency by reducing the 

amount of information that will be 

withheld when the Agency has 

discretion to determine what will be 

withheld under the FOIA exemptions, 

and will make release of information 

more efficient through the use of 

information technology. These 

amendments are required by the FOIA 

Improvement Act, and are currently part 

of FDA’s FOIA policy and procedures. 

• The proposed amendment to 

§ 20.22 would require FDA to indicate 

the exemption(s) under which 

information has been deleted at the site 

of the deletion. This change will inform 

requesters of the legal bases under 

which information has been withheld 

from Agency records, which promotes 

transparency. This change is required by 

the OPEN Government Act and was 

adopted by the Agency for FOIA 

processing as of the effective date of the 

OPEN Government Act. 

• The proposed amendment to 

§ 20.26 would require FDA to make 

available for public inspection in an 

electronic format records that have been 

requested three or more times under the 

FOIA. This change codifies the longstanding Department of Justice policy of 

federal agencies posting records that 

have been requested three or more 

times. The purpose of this change is to 

proactively release records to the public 

without the need for submission of 

additional FOIA requests. This change 

is required by the FOIA Improvement 

Act. 

• The proposed amendment to 

§ 20.33 would require FDA to offer the 

services of their FOIA Public Liaison 

and notify requesters of the services 

provided by the Office of Government 

Information Services (OGIS) when 

responding to FOIA requests. This 

change provides requesters with 

additional avenues for resolving FOIArelated disputes beyond the appeals 

process. This provision is required by 

the FOIA Improvement Act. 

• The proposed amendment to 

§ 20.40 updates the provision to include 

reference to the Agency’s online FOIA 

submission portal, which has been 

online since June 2012. 

• The proposed amendments to 

§ 20.41 would require that when FDA 

extends the time limit to respond to 

requests by more than 10 additional 

working days, FDA must notify the 

requester of the right to seek dispute 

resolution services from the FOIA 

Public Liaison and OGIS. This change 

provides requesters with additional 

avenues for resolving FOIA-related 

disputes beyond the appeals process. 


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We further amended the provision to 

provide that if a court determines that 

exceptional circumstances exist, the 

Agency’s failure to comply with a time 

limit shall be excused for the length of 

time provided by the court order. These 

changes are required by the FOIA 

Improvement Act. The revised provision 

further clarifies that the Agency may toll 

the response period once to seek more 

information from the requester, and 

more than once (if necessary) to clarify 

fee assessments. This revision is 

required by the OPEN Government Act. 

• The proposed amendment to 

§ 20.44 updates the title of the Agency 

official making determinations 

regarding requests for expedited 

processing. 

• The proposed amendments to 

§ 20.45 would modify the fee schedule 

to prohibit the Agency from assessing 

fees if the Agency fails to comply with 

time limits to respond and there are no 

unusual or exceptional circumstances 

that apply to the processing of the 

request. If unusual circumstances apply, 

these amendments establish a process 

by which the Agency can work with the 

requester to effectively limit the scope 

of the request. These changes will 

provide an incentive to the Agency to 

process requests as efficiently as 

possible, and will provide fee relief to 

requesters who do not receive FOIA 

responses in a timely manner. These 

provisions are required by the OPEN 

Government Act. Further amendments 

to this provision clarify how fees are 

calculated. 

• The proposed rule amends 

§ 20.49(c) to require full and partial 

denial letters to include contact 

information for the FOIA Public Liaison 

and OGIS, and to increase the time for 

transmittal of an appeal to 90 business 

days. We also made technical revisions 

to § 20.49(a) to update the position title 

of the Agency FOIA Officer, and to 

§ 20.49(c) to update the position title of 

the person to whom appeals shall be 

addressed. These changes provide 

requesters with additional avenues for 

resolving FOIA-related disputes beyond 

the appeals process and provide 

requesters with additional time to 

decide whether to pursue an appeal. 

These amendments are required by the 

FOIA Improvement Act. 

• The proposed rule amends 

§ 20.61(e)(2) to allow 10 days from the 

date of the notice for submitters of trade 

secrets or confidential commercial 

information to object to disclosure. This 

change will bring the Agency in line 

with departmental regulations. 

• The proposed rule amends § 20.62 

to prohibit the application of the 

deliberative process privilege of 

Exemption 5 of the FOIA to records 

created 25 years or more before the date 

on which the records were requested. 

This change will increase transparency 

by requiring the Agency to release 

information that could otherwise fall 

within the deliberative process privilege 

of the Exemption. This amendment is 

required by the FOIA Improvement Act. 

• The amendment to § 20.82 clarifies 

that the discretionary disclosure 

standard outlined in that provision will 

guide the Agency’s determinations of 

whether the Agency reasonably foresees 

that a disclosure of information would 

harm an interest protected by an 

exemption or disclosure is prohibited by 

law as required in administering 

§ 20.20. 

• The amendment to § 20.85 updates 

the statutory references. 

• The amendment to § 20.86 clarifies 

that the list of proceedings subject to the 

provision is not exclusive. 

• The amendments to § 20.88 clarify 

that the provisions also apply to local 

officials and remove references to 

position titles that no longer exist. 

• The amendments to § 20.89 remove 

references to position titles that no 

longer exist. 

• The amendments to § 20.100 update 

the regulatory cross-references. 

• The amendment to § 20.120 updates 

the contact information for the Agency’s 

reading rooms. 

• The amendment to 21 CFR 720.8 

revises the request for confidentiality of 

the identity of a cosmetic ingredient 

provision for consistency with FDA’s 

disclosure regulation at § 20.29. 

VI. Proposed Effective Date 

FDA proposes that any final rule that 

issues based on this proposal become 

effective 30 days after the final rule 

publishes in the Federal Register. 

VII. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 13771, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct us to assess all 

costs and benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). Executive Order 

13771 requires that the costs associated 

with significant new regulations ‘‘shall, 

to the extent permitted by law, be offset 

by the elimination of existing costs 

associated with at least two prior 

regulations.’’ We believe that this 

proposed rule is not a significant 

regulatory action as defined by 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the proposed revisions do not 

impose any burdens upon FOIA 

requesters, including those that might 

be small entities, we propose to certify 

that the proposed rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $150 million, 

using the most current (2017) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

We expect to incur negligible costs 

associated with implementing this rule. 

These costs result from updating titles 

of Agency officials, providing some 

additional information to FOIA 

requesters, and compiling information 

for annual reports. These requirements 

would not require more resources from 

us because we would perform these 

actions as part of our routine practices 

for FOIA processing. The proposed rule, 

if finalized, would enhance public 

access to government information as 

required by the FOIA Improvement Act. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) 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. 

IX. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by 

OMB under the Paperwork Reduction 

Act of 1995 is not required. 


daltland on DSKBBV9HB2PROD with PROPOSALS
46440 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively concluded that the rule 

does not contain policies that would 

have a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Accordingly, we conclude that a 

tribalism summary impact statement is 

not required. 

List of Subjects 

21 CFR Part 20 

Confidential business information, 

Courts, Freedom of information, 

Government employees. 

21 CFR Part 720 

Confidential business information, 

Cosmetics. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR parts 20 and 720 be amended as 

follows: 

PART 20—PUBLIC INFORMATION 

■ 1. The authority citation for part 20 

continues to read as follows: 

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 

U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401– 

1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 

243, 262, 263, 263b–263n, 264, 265, 300u– 

300u–5, 300aa–1. 

■ 2. Revise § 20.20 to read as follows: 

§ 20.20 Policy on disclosure of Food and 

Drug Administration records. 

(a) The Food and Drug Administration 

(FDA) will make the fullest possible 

disclosure of records to the public, 

consistent with the rights of individuals 

to privacy, the property rights of 

persons in trade secrets and confidential 

commercial or financial information, 

and the need for the Agency to promote 

frank internal policy deliberations and 

to pursue its regulatory activities 

without disruption. 

(b) Except where specifically exempt 

pursuant to the provisions of this part, 

all FDA records shall be made available 

for public disclosure. FDA will make 

discretionary disclosures of records or 

information exempt from disclosure 

under the provisions of this part 

whenever disclosure would not 

foreseeably harm an interest protected 

by an exemption pursuant to this part. 

This provision does not require 

disclosure of information that is 

prohibited from disclosure by law. 

(c) In accordance with the FOIA 

Improvement Act of 2016 (Pub. L. 114– 

185), FDA will establish procedures for 

identifying records of general interest or 

use to the public that are appropriate for 

public disclosure, and for posting and 

indexing such records in a publicly 

accessible electronic format. 

(d) Except as provided in paragraph 

(e) of this section, all nonexempt 

records shall be made available for 

public disclosure upon request 

regardless of whether any justification 

or need for such records have been 

shown. 

(e) ‘‘Record’’ and any other term used 

in this section in reference to 

information includes any information 

that would be an Agency record subject 

to the requirements of this part when 

maintained by the Agency in any 

format, including an electronic format. 

■ 3. In § 20.22, add paragraph (b)(3) to 

read as follows: 

§ 20.22 Partial disclosure of records. 

* * * * * 

(b) * * * 

(3) The exemption(s) under which the 

information has been deleted shall be 

noted at the site of the deletion. 

■ 4. In § 20.26, revise the section 

heading and paragraph (a)(4) to read as 

follows: 

§ 20.26 Electronic availability and indexes 

of certain records. 

(a) * * * 

(4) Records that have been released to 

any person in response to a Freedom of 

Information request and that the Agency 

has determined have become, or are 

likely to become, the subject of 

subsequent requests for substantially the 

same records or that have been 

requested three or more times. 

* * * * * 

■ 5. In § 20.33, add paragraph (c) to read 

as follows: 

§ 20.33 Form or format of response. 

* * * * * 

(c) Response letters shall contain 

contact information for the FOIA Public 

Liaison and the Office of Government 

Information Services as required by the 

FOIA Improvement Act of 2016 (Pub. L. 

114–185). 

■ 6. In § 20.40, revise paragraph (a) to 

read as follows: 

§ 20.40 Filing a request for records. 

(a) All requests for Food and Drug 

Administration records shall be made in 

writing by mailing or delivering the 

request to the Freedom of Information 

Staff at the address on the Agency’s 

website at https://www.fda.gov or by 

faxing it to the fax number listed on the 

Agency’s website at https://

www.fda.gov, or by submission through 

the Agency’s online FOIA submission 

portal at https://www.fda.gov. All 

requests must contain the postal address 

and telephone number of the requester 

and the name of the person responsible 

for payment of any fees that may be 

charged. 

* * * * * 

■ 7. In § 20.41, revise paragraphs 

(b)(3)(i)(A) and (b)(4), and add 

paragraphs (b)(5) and (d) to read as 

follows: 

§ 20.41 Time limitations. 

* * * * * 

(b) * * * 

(3)(i) * * * 

(A) The Agency may provide for an 

extension of up to 10 working days by 

providing written notice to the requester 

setting out the reasons for the extension 

and the date by which a determination 

is expected to be sent. In the written 

notice, the Agency will inform the 

requester of the right to contact the 

Freedom of Information Act Public 

Liaison and to seek dispute resolution 

services from the Office of Government 

Information Services. 

* * * * * 

(4) The Agency may contact the 

requester for clarification about the 

request or regarding fee assessment. The 

Agency may toll the 20-day period as 

follows: 

(i) One time while it is awaiting a 

response from the requester regarding 

clarification that it has reasonably 

requested from the requester; and 

(ii) One or more times while the 

Agency is awaiting a response from the 

requester regarding fee assessment. 

(5) If any record is denied, the letter 

shall state the right of the person 

requesting such records to appeal any 


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adverse determination to the Deputy 

Agency Chief Freedom of Information 

Act Officer, Department of Health and 

Human Services, in accordance with the 

provisions of 45 CFR 5.62. 

* * * * * 

(d) If a court determines that 

exceptional circumstances exist, as 

defined by the Freedom of Information 

Act, the Agency’s failure to comply with 

a time limit shall be excused for the 

length of time provided by the court 

order. 

■ 8. In § 20.44, revise paragraph (e) to 

read as follows: 

§ 20.44 Expedited processing. 

* * * * * 

(e) The Director, Division of Freedom 

of Information, (or Delegatee) will 

determine whether to grant a request for 

expedited processing within 10 days of 

receipt by the Division of Freedom of 

Information of all information required 

to make a decision. 

* * * * * 

■ 9. In § 20.45, revise paragraphs (a)(1) 

through (3), add paragraph (b)(7), and 

revise paragraphs (c)(1) and (2) to read 

as follows: 

§ 20.45 Fees to be charged. 

(a) * * * 

(1) Commercial use request. If the 

request is for a commercial use, the 

Food and Drug Administration will 

charge for the costs of search, review, 

and duplication. The Agency shall not 

assess search fees if the Agency fails to 

comply with any time limit, as 

described in § 20.41, if no unusual or 

exceptional circumstances apply to the 

processing of the request. If unusual 

circumstances, as outlined in § 20.41, 

apply and more than 5,000 pages are 

necessary to respond to the request, the 

Food and Drug Administration may 

charge search fees if timely written 

notice has been made to the requester 

and the Agency has discussed with the 

requester via written mail, electronic 

mail, 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. 

(2) Educational and scientific 

institutions and news media. If the 

request is from an educational 

institution or a noncommercial 

scientific institution, operated primarily 

for scholarly or scientific research, or a 

representative of the news media, and 

the request is not for a commercial use, 

the Food and Drug Administration will 

charge only for the duplication of 

documents. Also, the Food and Drug 

Administration will not charge the 

copying costs for the first 100 pages of 

duplication (or its cost equivalent of 

other media). The Agency shall not 

assess duplication fees if the Agency 

fails to comply with any time limit, as 

described in § 20.41, if no unusual or 

exceptional circumstances apply to the 

processing of the request. If unusual 

circumstances, as outlined in § 20.41, 

apply and more than 5,000 pages are 

necessary to respond to the request, the 

Food and Drug Administration may 

charge duplication fees if timely written 

notice has been made to the requester 

and the Agency has discussed with the 

requester via written mail, electronic 

mail, 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. 

(3) Other requests. If the request is not 

the kind described in paragraph (a)(1) or 

(2) of this section, then the Food and 

Drug Administration will charge only 

for the search and the duplication. Also, 

the Food and Drug Administration will 

not charge for the first 2 hours of search 

time or for the copying costs of the first 

100 pages of duplication (or the cost 

equivalent of other media). The Agency 

shall not assess search fees if the 

Agency fails to comply with any time 

limit, as described in § 20.41, if no 

unusual or exceptional circumstances 

apply to the processing of the request. 

If unusual circumstances, as outlined in 

§ 20.41, apply and more than 5,000 

pages are necessary to respond to the 

request, the Food and Drug 

Administration may charge search fees 

if timely written notice has been made 

to the requester and the Agency has 

discussed with the requester via written 

mail, electronic mail, 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. 

* * * * * 

(b) * * * 

(7) Requesters may contact Agency 

Freedom of Information Act staff or the 

Freedom of Information Act Public 

Liaison to assist in reformulating a 

request to meet their needs at lower 

cost. 

* * * * * 

(c) * * * 

(1) Manual searching for or reviewing 

of records. When the search or review 

is performed by employees at grade GS– 

1 through GS–8 (or equivalent), an 

hourly rate based on the salary of a GS– 

5, step 7, employee; when done by a 

GS–9 through GS–14 (or equivalent), an 

hourly rate based on the salary of a GS– 

12, step 4, employee; and when done by 

a GS–15 or above (or equivalent), an 

hourly rate based on the salary of a GS– 

15, step 7, employee. In each case, the 

hourly rate will be computed by taking 

the current hourly rate for the specified 

grade and step in the General Schedule 

Locality Pay Table for the Locality of 

Washington-Baltimore-Northern 

Virginia, DC–MD–VA–WV–PA, adding 

16 percent of that rate to cover benefits, 

and rounding to the nearest whole 

dollar. When a search involves 

employees at more than one of these 

levels, the Food and Drug 

Administration will charge the rate 

appropriate for each. 

(2) Electronic searching. Charges for 

the time spent by the operator to search 

the computer, database or network, 

including development of any 

specialized programming required to 

perform the search, at the rate given in 

paragraph (c)(1) of this section plus the 

cost of any materials. 

* * * * * 

■ 10. In § 20.49, revise paragraphs (a) 

and (c) and remove paragraph (d). 

The revisions read as follows: 

§ 20.49 Denial of a request for records. 

(a) A denial of a request for records, 

in whole or in part, shall be signed by 

the Director, Division of Freedom of 

Information, or other official who has 

been delegated the authority to release 

or withhold records. 

* * * * * 

(c) A letter denying a request for 

records, in whole or in part, shall state 

the reasons for the denial and shall state 

that an appeal may be transmitted to the 

Deputy Agency Chief Freedom of 

Information Act Officer, Department of 

Health and Human Services, within 90 

calendar days from the date of the 

adverse determination, in accordance 

with 45 CFR 5.61. The Agency will also 

make a reasonable effort to include in 

the letter an estimate of the volume of 

the records denied, unless providing 

such an estimate would harm an interest 

protected by an exemption under the 

Freedom of Information Act. This 

estimate will ordinarily be provided in 

terms of the approximate number of 

pages or some other reasonable measure. 

This estimate will not be provided if the 

volume of records denied is otherwise 

indicated through deletions on records 

disclosed in part. The letter will also 

include contact information for the 

Freedom of Information Act Public 

Liaison and the Office of Government 

Information Services. 

■ 11. In § 20.61, revise paragraph (e)(2) 

to read as follows: 

§ 20.61 Trade secrets and commercial or 

financial information which is privileged or 

confidential. 

* * * * * 

(e) * * * 


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(2) The submitter has 10 working days 

from the date of the notice to object to 

disclosure of any part of the records and 

to state all bases for its objections. 

Division of Freedom of Information may 

extend this period as appropriate and 

necessary. 

* * * * * 

■ 12. Revise § 20.62 to read as follows: 

§ 20.62 Inter- or intra-agency memoranda 

or letters. 

Inter-agency or intra-agency 

memoranda or letters that would not be 

available by law to a party other than an 

Agency in litigation with the Food and 

Drug Administration may be withheld 

from public disclosure except that 

factual information that is reasonably 

segregable in accordance with the rule 

established in § 20.22 is available for 

public disclosure. The deliberative 

process privilege shall not apply to 

records created 25 years or more before 

the date on which the records were 

requested. 

■ 13. In § 20.82, revise paragraph (a) to 

read as follows: 

§ 20.82 Discretionary disclosure by the 

Commissioner. 

(a) Except as provided in paragraph 

(b) of this section, the Commissioner 

may, in his or her discretion, disclose 

part or all of any Food and Drug 

Administration (FDA) record that is 

otherwise exempt from disclosure 

pursuant to subpart D of this part. As set 

forth in § 20.20(b) FDA shall make 

discretionary disclosures of records or 

information exempt from disclosure 

under the provisions of this part 

whenever disclosure would not 

foreseeably harm an interest protected 

by an exemption pursuant to this part. 

Specifically, FDA shall exercise its 

discretion to disclose such records 

whenever it determines that such 

disclosure is in the public interest, will 

promote the objectives of the Freedom 

of Information Act and the Agency, and 

is consistent with the rights of 

individuals to privacy, the property 

rights of persons in trade secrets, and 

the need for the Agency to promote 

frank internal policy deliberations and 

to pursue its regulatory activities 

without disruption. 

* * * * * 

■ 14. Revise § 20.85 to read as follows: 

§ 20.85 Disclosure to other Federal 

government departments and agencies. 

Any Food and Drug Administration 

(FDA) record otherwise exempt from 

public disclosure may be disclosed to 

other Federal government departments 

and agencies, except that trade secrets 

and confidential commercial or 

financial information prohibited from 

disclosure by 21 U.S.C. 331(j), 21 U.S.C. 

360j(c), 21 U.S.C. 360ll(d), 21 U.S.C. 

360nn(e) and 21 U.S.C. 387f(c) may be 

released only as provided by those 

sections. Any disclosure under this 

section shall be pursuant to a written 

agreement that the record shall not be 

further disclosed by the other 

department or Agency except with the 

written permission of the FDA. 

■ 15. Revise § 20.86 to read as follows: 

§ 20.86 Disclosure in administrative or 

court proceedings. 

Data and information otherwise 

exempt from public disclosure may be 

revealed in Food and Drug 

Administration (FDA) administrative 

proceedings, such as those pursuant to 

parts 10, 12, 13, 14, 15, 17, and 19 of 

this chapter or court proceedings, where 

data or information are relevant. The 

FDA will take appropriate measures, or 

request that appropriate measures be 

taken, to reduce disclosure to the 

minimum necessary under the 

circumstances. 

■ 16. In § 20.88, revise paragraphs (d)(1) 

introductory text, (d)(1)(i), (d)(1)(ii)(B) 

and (C), (d)(2), and (e)(1) and (3) to read 

as follows: 

§ 20.88 Communications with State and 

local government officials. 

* * * * * 

(d)(1) The Commissioner of Food and 

Drugs, or any other officer or employee 

of the Food and Drug Administration 

whom the Commissioner may designate 

to act on his or her behalf for the 

purpose, may authorize the disclosure 

of confidential commercial information 

submitted to the Food and Drug 

Administration, or incorporated into 

Agency-prepared records, to State and 

local government officials as part of 

cooperative law enforcement or 

regulatory efforts, provided that: 

(i) The State or local government 

agency has provided both a written 

statement establishing its authority to 

protect confidential commercial 

information from public disclosure and 

a written commitment not to disclose 

any such information provided without 

the written permission of the sponsor or 

written confirmation by the Food and 

Drug Administration that the 

information no longer has confidential 

status; and 

(ii) * * * 

(B) Disclosure would be in the interest 

of public health by reason of the State 

or local government’s possessing 

information concerning the safety, 

effectiveness, or quality of a product or 

information concerning an 

investigation, or by reason of the State 

or local government being able to 

exercise its regulatory authority more 

expeditiously than the Food and Drug 

Administration; or 

(C) The disclosure is to a State or local 

government scientist visiting the Food 

and Drug Administration on the 

Agency’s premises as part of a joint 

review or long-term cooperative training 

effort authorized under section 708 of 

the Federal Food, Drug, and Cosmetic 

Act, the review is in the interest of 

public health, the Food and Drug 

Administration retains physical control 

over the information, the Food and Drug 

Administration requires the visiting 

State or local government scientist to 

sign a written commitment to protect 

the confidentiality of the information, 

and the visiting State or local 

government scientist provides a written 

assurance that he or she has no financial 

interest in the regulated industry of the 

type that would preclude participation 

in the review of the matter if the 

individual were subject to the conflict of 

interest rules applicable to the Food and 

Drug Administration advisory 

committee members under § 14.80(b)(1) 

of this chapter. Subject to all the 

foregoing conditions, a visiting State or 

local government scientist may have 

access to trade secret information, 

entitled to protection under section 

301(j) of the Federal Food, Drug, and 

Cosmetic Act, in those cases where such 

disclosures would be a necessary part of 

the joint review or training. 

(2) Except as provided under 

paragraph (d)(1)(ii)(C) of this section, 

this provision does not authorize the 

disclosure to State and local government 

officials of trade secret information 

concerning manufacturing methods and 

processes prohibited from disclosure by 

section 301(j) of the Federal Food, Drug, 

and Cosmetic Act, unless pursuant to an 

express written authorization provided 

by the submitter of the information. 

* * * * * 

(e)(1) The Commissioner of Food and 

Drugs, or any other officer or employee 

of the Food and Drug Administration 

whom the Commissioner may designate 

to act on his or her behalf for the 

purpose, may authorize the disclosure 

to, or receipt from, an official of a State 

or local government agency of 

nonpublic, predecisional documents 

concerning the Food and Drug 

Administration’s or the other 

government agency’s regulations or 

other regulatory requirements, or other 

nonpublic information relevant to either 

agency’s activities, as part of efforts to 

improve Federal-State and/or Federallocal uniformity, cooperative regulatory 

activities, or implementation of FederalVerDate Sep<11>2014 18:19 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\FR\FM\13SEP1.SGM 13SEP1

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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 46443 

State and/or Federal-local agreements, 

provided that: 

(i) The State or local government 

agency has the authority to protect such 

nonpublic documents from public 

disclosure and will not disclose any 

such documents provided without the 

written confirmation by the Food and 

Drug Administration that the documents 

no longer have nonpublic status; and 

(ii) The Commissioner or his or her 

designee makes the determination that 

the exchange is reasonably necessary to 

improve Federal-State and/or Federallocal uniformity, cooperative regulatory 

activities, or implementation of FederalState and/or Federal-local agreements. 

* * * * * 

(3) For purposes of this paragraph, the 

term official of a State or local 

government agency includes, but is not 

limited to, an agent contracted by the 

State or local government, and an 

employee of an organization of State or 

local officials having responsibility to 

facilitate harmonization of State or local 

standards and requirements in the Food 

and Drug Administration’s areas of 

responsibility. For such officials, the 

statement and commitment required by 

paragraph (e)(1)(i) of this section shall 

be provided by both the organization 

and the individual. 

■ 17. In § 20.89, revise paragraph (d) to 

read as follows: 

§ 20.89 Communications with foreign 

government officials. 

* * * * * 

(d)(1) The Commissioner of Food and 

Drugs, or any other officer or employee 

of the Food and Drug Administration 

whom the Commissioner may designate 

to act on his or her behalf for the 

purpose, may authorize the disclosure 

to, or receipt from, an official of a 

foreign government agency of 

nonpublic, predecisional documents 

concerning the Food and Drug 

Administration’s or the other 

government agency’s regulations or 

other regulatory requirements, or other 

nonpublic information relevant to either 

agency’s activities, as part of 

cooperative efforts to facilitate global 

harmonization of regulatory 

requirements, cooperative regulatory 

activities, or implementation of 

international agreements, provided that: 

(i) The foreign government agency has 

the authority to protect such nonpublic 

documents from public disclosure and 

will not disclose any such documents 

provided without the written 

confirmation by the Food and Drug 

Administration that the documents no 

longer have nonpublic status; and 

(ii) The Commissioner or his or her 

designee makes the determination that 

the exchange is reasonably necessary to 

facilitate global harmonization of 

regulatory requirements, cooperative 

regulatory activities, or implementation 

of international agreements. 

(2) Any exchange under this section 

of nonpublic documents does not 

invoke the rule established in § 20.21 

that such records shall be made 

available to all members of the public. 

* * * * * 

■ 18. In § 20.100, revise paragraph 

(c)(6), remove and reserve paragraphs 

(c)(20) and (21), and add paragraphs 

(c)(47) through (51). 

The revision and additions read as 

follows: 

§ 20.100 Applicability; cross-reference to 

other regulations. 

* * * * * 

(c) * * * 

(6) Information on thermal processing 

of low-acid foods packaged in 

hermetically sealed containers, in 

§§ 108.25(k) and 108.35(l) of this 

chapter. 

* * * * * 

(47) Status reports of postmarketing 

study commitments in 

§§ 314.81(b)(2)(vii)(b) and 601.70(e) of 

this chapter. 

(48) Postmarket notification relating 

to shortages in § 600.82 of this chapter. 

(49) Postmarket notification relating 

to shortages in §§ 310.306 and 314.81 of 

this chapter. 

(50) Minor Species/Minor Use 

designation, in § 516.52 of this chapter. 

(51) Minor Species drug index listing, 

in § 516.171 of this chapter. 

■ 19. In § 20.120, revise paragraph (a) to 

read as follows: § 20.120 Records 

available in Food and Drug 

Administration Public Reading Rooms. 

(a) The Freedom of Information Staff 

and the Dockets Management Staff 

Public Reading Room are located at the 

same address. Both are located in Rm. 

1061, 5630 Fishers Lane, Rockville, MD 

20852. The telephone number for the 

Docket Management Staff is 240–402– 

7500; the telephone number for the 

Freedom of Information Staff’s Public 

Reading Room is located at the address 

on the Agency’s website at https://

www.fda.gov. Both public reading rooms 

are open from 9 a.m. to 4 p.m., Monday 

through Friday, excluding legal public 

holidays. 

* * * * * 

PART 720—VOLUNTARY FILING OF 

COSMETIC PRODUCT INGREDIENT 

COMPOSITION STATEMENTS 

■ 20. The authority citation for part 720 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 361, 362, 

371, 374. 

■ 21. In § 720.8, revise paragraphs (e) 

and (g) to read as follows: 

§ 720.8 Confidentiality of statements. 

* * * * * 

(e) If, after receiving all of the data 

that are necessary to make a 

determination about whether the 

identity of an ingredient is a trade 

secret, FDA tentatively decides to deny 

the request, the Agency will inform the 

person requesting trade secrecy of its 

tentative determination in writing. FDA 

will set forth the grounds upon which 

it relied in making this tentative 

determination. The petitioner may 

submit, within 60 days from the date of 

receipt of the written notice of the 

tentative denial, additional relevant 

information and arguments and request 

that the Agency reconsider its decision 

in light of both the additional material 

and the information that it originally 

submitted. 

* * * * * 

(g) A final determination that an 

ingredient is not a trade secret within 

the meaning of § 20.61 of this chapter 

constitutes final Agency action that is 

subject to judicial review under 5 U.S.C. 

Chapter 7. If suit is brought within 30 

calendar days after such a 

determination, FDA will not disclose 

the records involved or require that the 

disputed ingredient or ingredients be 

disclosed in labeling until the matter is 

finally determined in the courts. If suit 

is not brought within 30 calendar days 

after a final determination that an 

ingredient is not a trade secret within 

the meaning of § 20.61 of this chapter, 

the records involved will be available 

for public disclosure in accordance with 

part 20 of this chapter. 

Dated: September 7, 2018. 

Scott Gottlieb, 

Commissioner of Food and Drugs. 

[FR Doc. 2018–19864 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 


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