[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Proposed Rules]
[Pages 46437-46443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19864]


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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.

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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, [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary

[[Page 46438]]

    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
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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 Sec.  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 Sec.  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 Sec.  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 long-standing 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 Sec.  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 FOIA-related disputes 
beyond the appeals process. This provision is required by the FOIA 
Improvement Act.
     The proposed amendment to Sec.  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 Sec.  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.

[[Page 46439]]

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 Sec.  20.44 updates the title of 
the Agency official making determinations regarding requests for 
expedited processing.
     The proposed amendments to Sec.  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 Sec.  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 Sec.  
20.49(a) to update the position title of the Agency FOIA Officer, and 
to Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  20.20.
     The amendment to Sec.  20.85 updates the statutory 
references.
     The amendment to Sec.  20.86 clarifies that the list of 
proceedings subject to the provision is not exclusive.
     The amendments to Sec.  20.88 clarify that the provisions 
also apply to local officials and remove references to position titles 
that no longer exist.
     The amendments to Sec.  20.89 remove references to 
position titles that no longer exist.
     The amendments to Sec.  20.100 update the regulatory 
cross-references.
     The amendment to Sec.  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 Sec.  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.

[[Page 46440]]

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

0
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.

0
2. Revise Sec.  20.20 to read as follows:


Sec.  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.
0
3. In Sec.  20.22, add paragraph (b)(3) to read as follows:


Sec.  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.
0
4. In Sec.  20.26, revise the section heading and paragraph (a)(4) to 
read as follows:


Sec.  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.
* * * * *
0
5. In Sec.  20.33, add paragraph (c) to read as follows:


Sec.  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).
0
6. In Sec.  20.40, revise paragraph (a) to read as follows:


Sec.  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.
* * * * *
0
7. In Sec.  20.41, revise paragraphs (b)(3)(i)(A) and (b)(4), and add 
paragraphs (b)(5) and (d) to read as follows:


Sec.  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

[[Page 46441]]

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.
0
8. In Sec.  20.44, revise paragraph (e) to read as follows:


Sec.  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.
* * * * *
0
9. In Sec.  20.45, revise paragraphs (a)(1) through (3), add paragraph 
(b)(7), and revise paragraphs (c)(1) and (2) to read as follows:


Sec.  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 Sec.  
20.41, if no unusual or exceptional circumstances apply to the 
processing of the request. If unusual circumstances, as outlined in 
Sec.  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 Sec.  20.41, if no unusual or 
exceptional circumstances apply to the processing of the request. If 
unusual circumstances, as outlined in Sec.  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 Sec.  20.41, if no unusual or exceptional 
circumstances apply to the processing of the request. If unusual 
circumstances, as outlined in Sec.  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.
* * * * *
0
10. In Sec.  20.49, revise paragraphs (a) and (c) and remove paragraph 
(d).
    The revisions read as follows:


Sec.  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.
0
11. In Sec.  20.61, revise paragraph (e)(2) to read as follows:


Sec.  20.61  Trade secrets and commercial or financial information 
which is privileged or confidential.

* * * * *
    (e) * * *

[[Page 46442]]

    (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.
* * * * *
0
12. Revise Sec.  20.62 to read as follows:


Sec.  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 Sec.  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.
0
13. In Sec.  20.82, revise paragraph (a) to read as follows:


Sec.  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 Sec.  
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.
* * * * *
0
14. Revise Sec.  20.85 to read as follows:


Sec.  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.
0
15. Revise Sec.  20.86 to read as follows:


Sec.  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.
0
16. In Sec.  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:


Sec.  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 Sec.  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 Federal-local uniformity, cooperative 
regulatory activities, or implementation of Federal-

[[Page 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 Federal-local uniformity, cooperative regulatory 
activities, or implementation of Federal-State 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.
0
17. In Sec.  20.89, revise paragraph (d) to read as follows:


Sec.  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 Sec.  20.21 that such records shall be 
made available to all members of the public.
* * * * *
0
18. In Sec.  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:


Sec.  20.100  Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
    (6) Information on thermal processing of low-acid foods packaged in 
hermetically sealed containers, in Sec. Sec.  108.25(k) and 108.35(l) 
of this chapter.
* * * * *
    (47) Status reports of postmarketing study commitments in 
Sec. Sec.  314.81(b)(2)(vii)(b) and 601.70(e) of this chapter.
    (48) Postmarket notification relating to shortages in Sec.  600.82 
of this chapter.
    (49) Postmarket notification relating to shortages in Sec. Sec.  
310.306 and 314.81 of this chapter.
    (50) Minor Species/Minor Use designation, in Sec.  516.52 of this 
chapter.
    (51) Minor Species drug index listing, in Sec.  516.171 of this 
chapter.
0
19. In Sec.  20.120, revise paragraph (a) to read as follows: Sec.  
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

0
20. The authority citation for part 720 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.

0
21. In Sec.  720.8, revise paragraphs (e) and (g) to read as follows:


Sec.  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 Sec.  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 Sec.  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


