[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Proposed Rules]
[Pages 39003-39014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 5

RIN 0991-AC04


Freedom of Information Regulations

AGENCY: Office of the Secretary, Department of Health and Human 
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Department of Health and Human Services (HHS) is proposing 
to revise and republish its regulations implementing the Freedom of 
Information Act (FOIA). The regulations are being revised in order to 
incorporate changes made to the FOIA by the Openness Promotes 
Effectiveness in our National Government Act of 2007 (OPEN Government 
Act) and the Electronic FOIA Act of 1996 (E-FOIA Act). Additionally, 
the regulations are being updated to reflect changes to the 
organization, to make the FOIA process easier for the public to 
navigate, to update HHS's fee schedule, and to make provisions clearer. 
Because of the numerous changes to the organization and to the 
headings, the regulations are being republished in their entirety.

DATES: Submit comments on or before August 15, 2016.

ADDRESSES: You may submit comments via the Federal eRulemaking Portal 
at www.regulations.gov. In addition, please include the Docket ID at 
the top of your comments.

FOR FURTHER INFORMATION CONTACT: Michael Marquis, Michael Bell, Deborah 
Peters, and/or Brandon Lancey by email to: [email protected]. These 
individuals also can be reached by telephone at 202-690-7453.

SUPPLEMENTARY INFORMATION: This rule proposes revisions to the 
Department's regulations implementing the Freedom of Information Act 
(FOIA), 5 U.S.C. 552. The Department's FOIA regulations were last 
revised on November 23, 1988. Since that time, there have been major 
changes to the FOIA through the passage of the Openness Promotes 
Effectiveness in our National Government Act of 2007 (OPEN Government 
Act) (Pub. L. 110-175, 121 Stat. 2524) and the Electronic Freedom of 
Information Act Amendments of 1996 (E-FOIA Act) (Pub. L. 104-231, 110 
Stat. 3048). This revision proposes to update the regulations to make 
them consistent with the OPEN Government Act and the E-FOIA Act. In 
addition, these regulations are being updated to

[[Page 39004]]

reflect changes to the organization, to make the FOIA process easier 
for the public to navigate, to update HHS's fee schedule, and to make 
provisions clearer.

The OPEN Government Act

    The OPEN Government Act was enacted into law on December 31, 2007. 
Changes resulting from the enactment of the OPEN Government Act are 
found throughout this proposed rule. New provisions implementing the 
OPEN Government Act have been included in the following sections 
addressing the following subjects: Sec.  5.3 (Chief FOIA Officer); 
Sec.  5.3, Sec.  5.23(c), and Sec.  5.29(a) (FOIA Public Liaisons); 
Sec.  5.3 (definition of ``representative of the news media''); Sec.  
5.3, Sec.  5.25(c), and Sec.  5.41(f) (tolling of time limits); Sec.  
5.23(b) (receipt of requests); Sec.  5.25(a) (tracking numbers for all 
requests); Sec.  5.28(c) (indicate exemption under which redaction is 
made); Sec.  5.29(b) and Sec.  5.54(b) (references to the Office of 
Government Information Services (OGIS)); and Sec.  5.44(d) (ability to 
charge fees when a time limit is missed).

The E-FOIA ACT

    This revision proposes to update the regulations to make them 
consistent with the E-FOIA Act. New provisions implementing the E-FOIA 
Act have been included in the following sections addressing the 
following subjects: Sec.  5.1(b)(3)(iv) and Sec.  5.1(b)(3)(v) 
(additional category of reading room records and indexing of this 
category); Sec.  5.3 and Sec.  5.22(e) (electronic posting of reading 
room records); Sec.  5.3 (definition of ``record'' to include material 
stored electronically); Sec.  5.3 (definition of ``search'' to include 
electronic form or format); Sec.  5.25(e) (number of days to make 
disclosure decision increased from 10 working days to 20); Sec.  
5.25(e) and (f) (adoption of multi-track system for processing FOIA 
requests); Sec.  5.25(e), (f), (g), and (h) (FOIA requests involving 
``unusual circumstances''); Sec.  5.27 (expedited processing); Sec.  
5.28(b) (informing requesters about the amount of information 
redacted); and Sec.  5.28(f) (form and format of response).

Additional Changes

    The proposed rule revises the FOIA regulations in order to reflect 
the current organizational structure of the Department. Since the 
regulations were last revised, the following Operating Divisions and 
Staff Divisions were created: The Administration for Children and 
Families in 1991, the Administration for Community Living in 2012, the 
Agency for Healthcare Research & Quality in 1989, the Program Support 
Center in 1995, and the Substance Abuse and Mental Health Services 
Administration in 1992. In addition, the Health Care Financing 
Administration was renamed the Centers for Medicare & Medicaid Services 
in 2001 and the Social Security Administration became an independent 
agency, leaving the organization in 1995. Sections 5.3 and 5.23 have 
been updated to reflect these changes.
    The proposed rule establishes and defines the role of the Deputy 
Chief FOIA Officer at Sec.  5.3. The proposed rule also more clearly 
defines the role of the HHS Freedom of Information Officer in the 
Office of the Secretary and details this individual's responsibility 
for Department-wide administration and coordination of the Freedom of 
Information Act at Sec.  5.3. Finally, in Sec.  5.3, the departmental 
regulations have been amended to specify that each HHS Freedom of 
Information Officer has the authority to task agency organizational 
components to search for records in response to a FOIA request and 
provide records located to the cognizant FOIA office.
    The proposed rule makes a number of changes to assist the public in 
navigating the FOIA process. The new Sec.  5.2 asserts the Department's 
commitment to provide access to public records and increase openness 
and transparency. Section 5.22 has been further clarified to better 
inform requesters of the type of information they should include in a 
FOIA request. Sections 5.23 and 5.24 provide requesters with the 
information needed to submit a FOIA request electronically. Section 
5.25(a) creates procedures for acknowledging FOIA requests. Section 
5.25(c) describes how the FOIA Service Centers will attempt to seek 
clarification from requesters before closing ambiguous requests. 
Section 5.28(e) establishes a policy that encourages interim responses 
for requests that involve a voluminous amount of material or searches 
in multiple locations. Section 5.31(d)(4)(ii) increases the number of 
days to respond to a submitter notice from 5 working days to 10 working 
days and gives the Department and its Operating Divisions and Staff 
Divisions the option to extend this timeframe as necessary; this will 
allow submitters the opportunity to make more clearly articulated 
disclosure objections rather than seeking to broadly designate 
information as exempt. Section 5.52(a) provides the contact information 
for submitting an appeal and increases the number of calendar days 
within which an appeal must be received from 30 to 45. Finally, Sec.  
5.61 informs requesters of how long the Department retains records 
created in administering the Department's Freedom of Information 
Program.
    The proposed rule includes changes to the HHS fee schedule and 
other fee-related items. Revisions to the HHS fee schedule can be found 
at Sec.  5.43. The proposed rule also provides updated procedures for 
handling of advanced payments (Sec.  5.41(b)); negotiating fees (Sec.  
5.41(e)); and costs for reproducing electronic records (Sec.  
5.43(c)(2) and (3)), using special delivery (Sec.  5.43(d)), and 
certifying records (Sec.  5.43(e)). The proposed rule provides the 
Department the ability to waive fees as a matter of administrative 
discretion in Sec.  5.45(e). Finally, Sec.  5.42(b) increases the 
minimum threshold for fee charges.

Regulatory Analysis

Executive Order 12866

    The proposed rule has been drafted and reviewed in accordance with 
Executive Order 12866, 58 FR 51735 (Sept. 30, 1993), section 1(b), 
Principles of Regulation, and Executive Order 13563, 76 FR 3821 
(January 18, 2011), Improving Regulation and Regulatory Review. The 
proposed rule is not a ``significant regulatory action'' under section 
3(f) of Executive Order 12866. Accordingly, the rulemaking has not been 
reviewed by the Office of Management and Budget.

Regulatory Flexibility Act

    The Department certifies under 5 U.S.C. 605(b) that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities because the proposed revisions do not impose 
any burdens upon FOIA requesters, including those that might be small 
entities. Therefore, a regulatory flexibility analysis is not required 
by the Regulatory Flexibility Act.

Unfunded Mandates Reform Act of 1995

    The proposed rule will not result in the expenditure by State, 
local, or tribal governments in the aggregate, or by the private 
sector, of $100 million or more in any one year, and it will not 
significantly or uniquely affect small governments. Therefore, no 
actions are deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Executive Order 12612

    This proposal has been reviewed under Executive Order 12612, 
Federalism, and it has been determined that it does not have sufficient 
implications for federalism to warrant preparation of a Federalism 
Assessment.

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Paperwork Reduction Act

    The proposed rule contains no new information collection 
requirements subject to review by the Office of Management and Budget 
under the Paperwork Reduction Act (44 U.S.C. chapter 35).

List of Subjects in 45 CFR Part 5

    Freedom of information.

    In consideration of the foregoing, HHS proposes to revise part 5 of 
title 45, Code of Federal Regulations, to read as follows:

PART 5--FREEDOM OF INFORMATION REGULATIONS

Subpart A--General Information About Freedom of Information Act 
Requests
Sec.
5.1 Purpose.
5.2 Presumption of openness and proactive disclosures.
5.3 Definitions.
5.4 Regulatory scope.
5.5 Interrelationship between the FOIA and the Privacy Act of 1974.
Subpart B--How To Request Records Under FOIA
5.21 Who can file a FOIA request?
5.22 What do I include in my FOIA request?
5.23 Where do I send my FOIA request?
5.24 Does HHS accept electronic FOIA requests?
5.25 How does HHS process my FOIA request?
5.26 How does HHS determine estimated completion dates for FOIA 
requests?
5.27 How do I request expedited processing?
5.28 How does HHS respond to my request?
5.29 How may I request assistance with the FOIA process?
Subpart C--Exemptions to Disclosure
5.31 What are the reasons records may be withheld?
5.32 Records not subject to the requirements of the FOIA--law 
enforcement exclusions.
Subpart D--Fees
5.41 General information on fees for all FOIA requests.
5.42 What fee policies apply to HHS records?
5.43 What is the FOIA fee schedule for obtaining records?
5.44 How does HHS calculate FOIA fees for different categories of 
requesters?
5.45 How may I request a fee waiver?
Subpart E--Appeals
5.51 When may I appeal HHS's FOIA determination?
5.52 How do I file an appeal?
5.53 How does HHS process appeals?
5.54 What avenues are available to me if I disagree with HHS's 
appeal decision?
Subpart F--Records Retention
5.61 How does HHS retain FOIA records?

    Authority: 5 U.S.C. 552, 18 U.S.C. 1905, 31 U.S.C. 9701, 42 
U.S.C. 1306(c), E.O. 12600, E.O. 13392.

Subpart A--General Information About Freedom of Information Act 
Requests


Sec.  5.1  Purpose.

    This part implements the provisions of the Freedom of Information 
Act (FOIA), 5 U.S.C. 552, as amended, for Department of Health and 
Human Services (HHS) records that are subject to the FOIA. This part 
contains the rules that we follow to process FOIA requests, such as the 
amount of time we have to make a determination regarding the release of 
records, who can decide to release records and who can decide not to 
release them, the fees we may charge, if applicable, the reasons why 
some records are exempt from disclosure under the FOIA, and the 
administrative and legal remedies available should a requester disagree 
with our initial disclosure determination.
    (a) The FOIA provides a right of access to agency records, except 
to the extent that any portions of the records are protected from 
public disclosure by an exemption or exclusion in the statute. The FOIA 
does not require us to perform research for you or to answer your 
questions. The FOIA does not require agencies to create new records or 
to perform analysis of existing records; for example, by extrapolating 
information from existing agency records, reformatting publicly 
available information, preparing new electronic programs or databases, 
or creating data through calculations of ratios, proportions, 
percentages, trends, frequency distributions, correlations, or 
comparisons. However, at our discretion and if it would conserve 
government resources, we may decide to supply requested information by 
consolidating information from various records.
    (b) This part does not apply to:
    (1) Records that are currently available, either from HHS or from 
another Federal government agency, under a statute that provides for 
charging fees for those records;
    (2) Records that have been made publicly available by an HHS Staff 
Division or Operating Division or other Federal agency, as part of its 
regular program activity;
    (3) Records that have been affirmatively and continuously posted 
online as required by subsection (a)(2) of the FOIA, which includes the 
following categories of records:
    (i) Final opinions, including concurring and dissenting opinions, 
as well as orders, made in the adjudication of cases;
    (ii) Those statements of policy and interpretations which have been 
adopted by the agency and are not published in the Federal Register;
    (iii) Administrative staff manuals and instructions to staff that 
affect a member of the public;
    (iv) Frequently requested records; and
    (v) A general index of the records referred to under paragraph 
(b)(3)(iv) of this section;
    (4) Data generated by an agency grant recipient under the 
provisions of 45 CFR part 75 to the extent the requirements of 45 CFR 
75.322(e) do not apply to the data. We will not process your request 
under the FOIA or these regulations if that data is already available 
to the public through an archive or other source. In that situation, we 
will refer you to that other source; and
    (5) Records requested from the System Manager of a Privacy Act 
system of records, pursuant to access provisions contained in the 
system's System of Records Notice (as described in 5 U.S.C. 
552a(e)(4)), if the access request is fully granted by the System 
Manager under the Privacy Act, so that it is unnecessary to process the 
request under the FOIA. For information pertaining to the Privacy Act, 
please refer to 5 U.S.C. 552a, and the Department's Privacy Act 
regulations at 45 CFR part 5b. Privacy Act exemptions are not addressed 
in this regulation; they are addressed at 45 CFR 5b.11, and in the 
Privacy Act at 5 U.S.C. 552a(d)(5), (j), and (k).


Sec.  5.2  Presumption of openness and proactive disclosures.

    In administering the FOIA, we are committed to providing access to 
public records as part of the Department's efforts to increase openness 
and transparency, but with due regard for protecting the legitimate 
interests of entities that have submitted records to the Department, 
the privacy interests of individuals who would be affected by release 
of records, and the interests of the agency in creating policy, making 
operating decisions and carrying out its mission.
    (a) It is our policy to respond to all requests for records, 
irrespective of whether those requests conform to the requirements of 
these regulations. However, in order to preserve rights given to you by 
the FOIA and by this regulation (for example, the right to appeal if we 
deny your request and the right to have our appeal decision reviewed by 
a court), your request must be in writing and make reference to the 
FOIA. In certain exceptional circumstances, a Freedom of Information 
Office may, at its discretion,

[[Page 39006]]

accept an oral request from you and reduce it to writing for you.
    (b) [Reserved]


Sec.  5.3  Definitions.

    The following definitions apply to this part:
    Agency is defined at 5 U.S.C. 551(1). HHS is an agency. Private 
entities performing work under a contractual agreement with the 
government are not agencies for the purpose of this definition. 
However, information maintained for an agency under Government 
contract, for the purposes of records management, is considered an 
agency record.
    Chief FOIA Officer means a senior official of HHS, at the Assistant 
Secretary or equivalent level, who has agency-wide responsibility for 
ensuring efficient and appropriate compliance with the FOIA, monitoring 
implementation of the FOIA throughout the agency, and making 
recommendations to the head of the agency to improve the agency's 
implementation of the FOIA. The Secretary of HHS has designated the 
Assistant Secretary, Office of the Assistant Secretary for Public 
Affairs (ASPA), as the Agency Chief FOIA Officer (ACFO); that official 
may be contacted at [email protected].
    Commercial use means a use or purpose that furthers a commercial, 
trade, or profit interest of the requester or the person or entity on 
whose behalf the request is made.
    Department or HHS means the U.S. Department of Health and Human 
Services.
    Deputy Agency Chief FOIA Officer (DACFO) means a designated 
official within the Office of the Assistant Secretary for Public 
Affairs, who has been authorized by the Chief FOIA Officer to act upon 
their behalf to implement compliance with the FOIA, as described above. 
This official is also the approving review authority for FOIA 
administrative appeals.
    Direct costs mean those expenses that an agency incurs in searching 
for and duplicating (and, in the case of commercial use requests, 
reviewing) records in order to respond to a FOIA request. For example, 
direct costs include the salary of the employee performing the work 
(i.e., the basic rate of pay for the employee, plus 16 percent of that 
rate to cover benefits) and the cost of operating computers and other 
electronic equipment, such as photocopiers and scanners. Direct costs 
do not include overhead expenses such as the costs of space, and of 
heating or lighting a facility.
    Duplication means the process of making a copy of a record and 
sending it to the requester, to the extent necessary to respond to the 
request. Such copies include both paper copies and electronic records. 
Fees for duplication are further explained within Sec.  5.43.
    Educational institution means a school, university, or other entity 
of learning that operates a program of scholarly research. To qualify 
for this category, a requester must show that the request is authorized 
by, and is made under the auspices of, a qualifying institution and 
that the records are sought to further a scholarly research goal of the 
institution, and not for a commercial use or purpose, or for individual 
use or benefit.
    Expedited processing means the process set forth in the FOIA that 
allows requesters to request faster processing of their FOIA request, 
if they can demonstrate a specific compelling need.
    Fee category means one of the four categories established by the 
FOIA to determine whether a requester will be charged fees for search, 
review, and duplication. The categories are: Commercial use requests; 
non-commercial scientific or educational institutions requests; news 
media requests; and all other requests. Fee categories are further 
explained within Sec.  5.44.
    Fee waiver means the waiver or reduction of fees if a requester is 
able to demonstrate that certain standards set forth in the FOIA and 
this part are satisfied, including that disclosure of the records is in 
the public interest and that the records are not requested to further a 
commercial interest.
    First-party request means a request by an individual for records 
pertaining to that individual, or an authorized representative acting 
upon an individual's behalf.
    FOIA Public Liaison means an agency official who reports to the 
agency Chief FOIA Officer and serves as a supervisory official to whom 
a requester can raise concerns about the service the requester has 
received from the FOIA Service Center. This individual is responsible 
for assisting in reducing delays, increasing transparency, and 
understanding of the status of requests, and assisting in the 
resolution of disputes.
    FOIA request means a written request, which reasonably describes 
the records sought. We may contact a requester to clarify the records 
that are sought or to discuss the scope of the request.
    Freedom of Information Act (FOIA) means the law codified at 5 
U.S.C. 552 that provides the public with the right to request agency 
records from Federal executive branch agencies. A link to the text of 
the FOIA is at http://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/amended-foia-redlined-2010.pdf.
    Freedom of Information Officer means an HHS official who has been 
delegated the authority to release or withhold records; to assess, 
waive, or reduce fees in response to FOIA requests; and to determine 
whether to grant expedited processing. In that capacity, the Freedom of 
Information Officer has the authority to task agency organizational 
components to search for records in response to a FOIA request, and to 
provide records located in their office. Apart from records subject to 
proactive disclosure pursuant to subsection (a)(2) of the FOIA, only 
Freedom of Information Officers have the authority to release or 
withhold records or to waive fees in response to a FOIA request. Our 
FOIA operations are decentralized, and each FOIA Service Center listed 
in Sec.  5.23 has a designated official with this authority; the 
contact information for each FOIA Service Center is also listed in 
Sec.  5.23.
    (1) The HHS Freedom of Information Officer in the Office of the 
Secretary means the HHS official who in addition to overseeing the 
daily operations of the FOIA program in that office and having the 
authority of a Freedom of Information Officer, is also responsible for 
the Department-wide administration and coordination of the FOIA and its 
implementing regulations and policies as they pertain to the programs 
and activities of the Department. This individual serves as the 
principal resource with respect to the articulation of procedures 
designed to implement and ensure compliance with the FOIA and its 
implementing regulations and policies as they pertain to the 
Department. This individual reports through the DACFO to the ACFO to 
support oversight and compliance with the OPEN Government Act.
    (2) Operating Division and Staff Division Freedom of Information 
Officers means the officials who are responsible for overseeing the 
daily operations of their FOIA programs in their respective Operating 
Divisions or Staff Divisions of the Department, with the full authority 
as described in the definition of Freedom of Information Officer in 
this section. These individuals serve as the principal resource and 
authority for FOIA operations and implementation within their 
respective Operating Divisions or Staff Divisions.
    Frequently requested records means records, regardless of form or 
format,

[[Page 39007]]

that have been released to any person under the FOIA and that, because 
of the nature of their subject matter, the agency determines have 
become or are likely to become the subject of subsequent requests for 
substantially the same records.
    Immediate Office of the Secretary (IOS) means the Office of the 
Secretary, responsible for operations and work of the Secretary. It 
includes the Office of the Deputy Secretary, Office of the Chief of 
Staff, Secretary's Counselors, the Executive Secretariat, the Office of 
Health Reform, and the Office of Intergovernmental and External 
Affairs.
    Non-commercial scientific institution means an institution that is 
operated for the purpose of conducting scientific research and not at 
all on a basis that furthers the commercial, trade, or profit interests 
of any person or organization. We decide whether to grant a requester 
non-commercial status on a case-by-case basis, based on the requester's 
intended use of the requested records.
    Office of the Inspector General (OIG) means the Staff Division 
within the Office of the Secretary (OS), which is responsible for 
protecting the integrity of HHS programs and the health and welfare of 
the beneficiaries of those programs. OIG is responsible for processing 
FOIA requests sent to its Office.
    Office of the Secretary (OS) means the HHS's chief policy officer 
and general manager, who administers and oversees the organization, its 
programs and activities. The Deputy Secretary and a number of Assistant 
Secretaries and Staff Divisions support OS. The HHS FOIA Office within 
ASPA processes FOIA requests for records maintained by OS Staff 
Divisions other than the OIG and the Program Support Center (PSC). In 
certain circumstances and at the HHS FOIA Office's discretion, the HHS 
FOIA office may also process FOIA requests involving other HHS OpDivs, 
as further described in Sec.  5.28(a).
    Operating Divisions (OpDivs) means any of the following divisions 
within HHS which are subject to this regulation:

Office of the Secretary (OS)
Administration for Children and Families (ACF)
Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Substance Abuse and Mental Health Services Administration (SAMHSA).

    Other requester means any individual or organization whose request 
does not qualify as a commercial-use request, representative of the 
news media request (including a request made by a freelance 
journalist), or an educational or non-commercial scientific institution 
request.
    Program Support Center (PSC) means the Program Support Center. The 
PSC FOIA Office is located within the Office of Assistant Secretary for 
Administration (ASA) (i.e., within an OS Staff Division) and processes 
FOIA requests for certain OS records and FOIA requests and FOIA appeals 
for certain HHS OpDivs, as further described in Sec.  5.23.
    Reading room records are records that are required to be made 
available to the public without a specific request under 5 U.S.C. 
552(a)(2). As referenced in Sec.  5.1(b)(3), we make reading room 
records available to the public electronically through our Web pages 
(http://www.hhs.gov/foia/reading/index.html) and at the physical 
locations identified in Sec.  5.23. Other records may also be made 
available at our discretion through our Web pages (http://www.hhs.gov).
    Record means any information that would be an agency record when 
maintained by an agency in any format, including an electronic format; 
and any information that is maintained for an agency by an entity under 
Government contract, for the purposes of records management. This 
definition does not include materials available from the agency's 
libraries and reading rooms.
    Redact means delete or mark over.
    Representative of the news media means any person or entity that 
actively gathers information of potential interest to a segment of the 
public, uses its editorial skills to turn raw materials into a distinct 
work, and distributes that work to an audience. The term ``news'' means 
information that is about current events or that would be of current 
interest to the public. Examples of news media entities include 
television or radio stations that broadcast news to the public at large 
and publishers of periodicals, including print and online publications 
that disseminate news and make their products available through a 
variety of means to the general public. We do not consider requests for 
records that support the news-dissemination function of the requester 
to be a commercial use. We consider ``freelance'' journalists who 
demonstrate a solid basis for expecting publication through a news 
media entity as working for that entity. A publishing contract provides 
the clearest evidence that a journalist expects publication; however, 
we also consider a requester's past publication record. We decide 
whether to grant a requester media status on a case-by-case basis, 
based on the requester's intended use of the requested records.
    Review means examining records responsive to a request to determine 
whether any portions are exempt from disclosure. Review time includes 
processing a record for disclosure (i.e., doing all that is necessary 
to prepare the record for disclosure), including redacting the record 
and marking the appropriate FOIA exemptions.
    Search means the process of identifying, locating, and retrieving 
records to find records responsive to a request, whether in hard copy 
or in electronic form or format.
    Staff Divisions (StaffDivs) means an organization component that 
provides leadership, direction, and policy and management guidance to 
the Office of the Secretary and the Department. The following StaffDivs 
are subject to the regulations in this part:

Immediate Office of the Secretary (IOS)
Assistant Secretary for Administration (ASA)
Assistant Secretary for Financial Resources (ASFR)
Assistant Secretary for Health (OASH)
Assistant Secretary for Legislation (ASL)
Assistant Secretary for Planning and Evaluation (ASPE)
Assistant Secretary for Public Affairs (ASPA)
Assistant Secretary for Preparedness and Response (ASPR)
Departmental Appeals Board (DAB)
Office of Civil Rights (OCR)
Office of the General Counsel (OGC)
Office of Global Affairs (OGA)
Office of the Inspector General (OIG)
Office of Medicare Hearings and Appeals (OMHA)
Office of the National Coordinator for Health Information Technology 
(ONC)

    Submitter means any person or entity that provides commercial 
information to the agency, and includes individuals, corporations, 
other organizational entities, and state and foreign governments.
    Tolling means temporarily stopping the running of a time limit. We 
may toll a request to seek clarification or to address fee issues, as 
further described in Sec.  5.25.

[[Page 39008]]

Sec.  5.4  Regulatory scope.

    The requirements in this part apply to all OpDivs and StaffDivs of 
HHS. Some OpDivs and StaffDivs may establish or continue to maintain 
additional rules because of unique program requirements, but such rules 
must be consistent with this part, the FOIA and the precedential case 
law which interprets it. If additional rules are issued, they must be 
published in the Federal Register and you may get copies online at 
https://www.federalregister.gov/, http://www.regulations.gov/ or by 
contacting one of our FOIA Service Centers.


Sec.  5.5  Interrelationship between the FOIA and the Privacy Act of 
1974.

    The FOIA allows any person (whether an individual or entity) to 
request access to any Federal agency record. The Privacy Act, at 5 
U.S.C. 552a(d), provides an additional right of access, allowing 
individuals to request records about themselves, if the records are 
maintained in a system of records (defined in 5 U.S.C. 552a(a)(5)).
    (a) Requesting your own records: If you request records about 
yourself that are maintained within a system of records as defined by 
the Privacy Act, you should make your request in accordance with the 
Privacy Act and the Department's implementing regulations at 45 CFR 
part 5b. This includes requirements to verify your identity. If you 
request records about someone other than yourself, you may receive 
greater access if you submit appropriate documentation signed by the 
other person that certifies their identity and confirms that they have 
given their consent for you to have access to their records. If any of 
the FOIA Service Centers receive a Privacy Act request, they will 
forward it to the appropriate Privacy Act Officer. If you are an 
individual requesting your own records as described in this section, 
your request will be processed under the Privacy Act in coordination 
with the appropriate Privacy Act Officer. If an exemption under the 
Privacy Act applies, you may still be able to access your records, or a 
portion thereof, under the FOIA.
    (b) Requesting another individual's record. If you request records 
that are about an individual other than yourself and do not have that 
individual's written consent (including authentication of that 
individual's identity), we will process your request under the FOIA.

Subpart B--How To Request Records Under FOIA


Sec.  5.21  Who can file a FOIA request?

    Any individual, partnership, corporation, association, or public or 
private organization other than a Federal agency, regardless of 
nationality, may submit a FOIA request to us. The FOIA excludes Federal 
agencies from filing FOIA requests. However, state and local 
governments may file FOIA requests.


Sec.  5.22  What do I include in my FOIA request?

    In your FOIA request:
    (a) Describe the records you seek in sufficient detail to enable 
our staff to locate them with a reasonable amount of effort. The more 
information you provide, the better possibility we have of finding the 
records you are seeking. Information that will help us find the records 
would include:
    (1) The agencies, offices, or individuals involved;
    (2) The approximate date(s) when the records were created;
    (3) The subject, title, or description of the records sought; and
    (4) Author, recipient, case number, file designation, or other 
reference number, if available.
    (b) Include your name, full mailing address, and phone number and 
if available, your email address. This information allows us to reach 
you faster if we have any questions about your request. It is your 
responsibility to keep your current mailing address up to date with the 
office where you have filed the FOIA request.
    (c) If you are requesting the medical records of an individual 
other than yourself and you are not that individual's legally 
authorized representative, you should submit a Health Insurance 
Portability and Accountability Act (HIPAA) compliant release 
authorization form signed by the subject of records or the individual's 
legally authorized representative. The HIPAA Privacy Rule requires that 
an authorization form contain certain core elements and statements 
which are described in the Privacy Rule's requirements at 45 CFR 
164.508. If you are submitting a request for Medicare records to CMS, 
CMS has a release authorization form at the following link: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10106.pdf.
    (d) Mark both your letter and envelope, or the subject line of your 
email, with the words ``FOIA Request.''
    (e) Before filing your request, you may find it helpful to consult 
the HHS FOIA Service Centers online at http://www.hhs.gov/foia/contacts/index.html, which provides additional guidance to assist in 
submitting a FOIA request to a specific HHS OpDiv or StaffDiv or to 
regional offices or divisions within an OpDiv or StaffDiv. You may also 
wish to check in the agency's electronic reading rooms available online 
at http://www.hhs.gov/foia/reading/index.html, to see if the 
information you wish to obtain is already available.


Sec.  5.23  Where do I send my FOIA request?

    We have several FOIA Service Centers (FOIA offices) that process 
FOIA requests. You should send your FOIA request to the appropriate 
FOIA Service Center that you believe would have the records you seek. 
An up-to-date listing is maintained online at http://www.hhs.gov/foia/contacts/index.html.
    (a) If you are requesting research data made available under the 
provisions of 45 CFR 75.322(e), requests for such data should be 
addressed to the HHS OpDiv that made the award under which the data 
were first produced. That OpDiv will process your request in accordance 
with established procedures consistent with the FOIA and 45 CFR 
75.322(e).
    (b) We officially receive your request when it reaches the FOIA 
Service Center with responsibility for the HHS OpDiv or StaffDiv where 
requested records are likely to be located, but no later than 10 
working days after the request first arrives at any of our FOIA Service 
Centers.
    (c) If you have questions concerning the processing of your FOIA 
request, you may contact the FOIA Service Center processing your 
request. If that initial contact does not resolve your concerns, you 
may wish to contact the designated FOIA Public Liaison for the OpDiv or 
StaffDiv processing your request. You can find a list of our FOIA 
Service Centers and Public Liaisons at http://www.hhs.gov/foia/contacts/index.html.


Sec.  5.24  Does HHS accept electronic FOIA requests?

    Yes. The body of the message should contain all of the information 
listed in Sec.  5.22. You also may file a FOIA request by emailing your 
request to the appropriate FOIA Service Center, as listed in the table 
provided in Sec.  5.23. If an OpDiv or StaffDiv does not have a 
separate email or electronic link to submit a FOIA request, you may 
submit a FOIA request at the Department's main link at https://requests.publiclink.hhs.gov/palMain.aspx.

[[Page 39009]]

Sec.  5.25  How does HHS process my FOIA request?

    (a) Acknowledgement. We acknowledge all FOIA requests in writing 
within 10 working days after receipt by the appropriate office. The 
acknowledgement letter or email informs you of your request tracking 
number, provides contact information, and informs you of any complexity 
we are aware of in processing that may lengthen the time required to 
reach a final decision on the release of the records. The 
acknowledgement letter or email or a subsequent communication may also 
seek additional information to clarify your request or to ask you to 
narrow the scope of a very large or broad request. Should we ascertain 
at any time while processing your request that another agency may 
possess the requested records, we will either refer your request to 
that agency and notify you of that referral, or advise you how to 
contact that agency.
    (b) Perfected requests. (1) A request is considered to be perfected 
(i.e., the 20 working day statutory response time begins to run) when--
    (i) The request is received by the responsible FOIA office;
    (ii) The requested records are reasonably described;
    (iii) The request contains sufficient information to enable the 
FOIA office to contact the requestor and transmit records to the 
requestor; and
    (iv) The requester has agreed to pay all or an established amount 
of applicable fees or requested a fee waiver.
    (2) We provide at least 10 working days for you to respond to a 
request to perfect your request, after notification. Should you not 
answer any correspondence, or should the correspondence be returned as 
undeliverable, we reserve the right to administratively close the FOIA 
request.
    (c) Stops in processing time (tolling). We may stop the processing 
of your request one time if we require additional information regarding 
the specifics of the request. Requests must reasonably describe the 
records sought and not be overly broad. If we determine that a request 
does not reasonably describe the records sought, we will attempt to 
contact you using the contact information you have provided. The 
processing time resumes upon our receipt of your response. We also may 
stop the processing of your request if we require clarification 
regarding fee assessments. If additional information or clarification 
is required, we will attempt to contact you using the contact 
information you have provided. The processing time will resume upon our 
receipt of your response. We will provide at least 10 working days 
after notification for you to respond to a request for additional 
information or clarification regarding the specifics of your request or 
fee assessment. Should you not answer any correspondence, or should the 
correspondence be returned as undeliverable, we reserve the right to 
administratively close the FOIA request.
    (d) Search cut-off date. As the end or cut-off date for a records 
search, we use the date on which we first begin our search for 
documents responsive to your request, unless you specify an earlier 
cut-off date, or a specific date range for the records search. We will 
use the date of the first search in those cases when you request 
records ``through the present,'' ``through today,'' or similar 
language. The FOIA allows you to request existing agency records. The 
FOIA cannot be used to request records which the agency may create in 
the future in the course of carrying out its mission.
    (e) Processing queues. We place FOIA requests in simple or complex 
processing queues to be processed in the order received, on a first-in, 
first-out basis, absent approval for expedited processing based upon a 
compelling need, as further explained and defined in Sec.  5.27. For 
most non-expedited requests, we make a determination about release of 
the records you requested within 20 working days from when the 
appropriate office receives your request (simple queue processing). 
However, if unusual circumstances prevent us from making a decision 
within 20 working days, we will place your request into a complex 
processing queue, so that such cases do not delay the processing of 
simpler requests. We will notify you of potential complicating factors 
in our acknowledgement letter or email, or in subsequent communications 
regarding your request, and you may choose to limit the scope of your 
request to reduce the processing time for your request.
    (f) Complex processing queue factors. We will place into a complex 
processing queue any request that cannot be completed within 20 working 
days due to unusual circumstances. You will be notified if it is 
necessary for us to take an additional ten working days to process your 
request. Unusual circumstances include the need to:
    (1) Search for and collect the records from one or more offices or 
field locations that are separate from the office processing the 
request;
    (2) Search for, collect, and review a voluminous number of records 
that are part of a single request;
    (3) Consult with another OpDiv, StaffDiv or another agency having a 
substantial interest in the request before releasing records.
    (g) Aggregating requests. For the purposes of satisfying unusual 
circumstances, we may aggregate requests in cases where it reasonably 
appears that multiple requests, submitted either by a requester or by a 
group of requesters acting in concert, constitute a single request, 
involving clearly related matters, that would otherwise involve unusual 
circumstances. In the event that requests are aggregated, they will be 
treated as one request for the purposes of calculating both response 
time and fees.
    (h) Complex processing schedule. If we need to extend the deadline 
for more than an additional 10 working days as a result of unusual 
circumstances, we will ask if you wish to modify your request so that 
we can answer the request more quickly. If you do not wish to modify 
your request, we will provide you with an estimated date by which we 
expect to provide a response to your request.


Sec.  5.26  How does HHS determine estimated completion dates for FOIA 
requests?

    (a) When you ask for an estimated completion date for the 
processing of records that do not require consultation with another 
agency, we estimate the completion date on the basis of our reasonable 
judgment as to how long it will take to complete the request. Given the 
uncertainty inherent in establishing any estimate, the estimated 
completion date is subject to change at any time.
    (b) When you ask for an estimated completion date for records that 
must be reviewed by another agency, our estimate may also be based on 
information from the other agency.


Sec.  5.27  How do I request expedited processing?

    (a) We can expedite requests, or segments of requests, only for 
records over which we have control. If we must refer a request to 
another agency, we will inform you and suggest that you seek expedited 
review from that agency.
    (b) To request expedited processing, you must submit a statement, 
certified to be true and correct, explaining the basis for your need 
for expedited processing. You must send the request to the appropriate 
FOIA Officer at the address listed in Sec.  5.23. You may request 
expedited processing when you first request records or at any time 
during our processing of your request or appeal.
    (c) We process requests on an expedited basis whenever we determine

[[Page 39010]]

that one or more of the following criteria exist:
    (1) That a failure to obtain requested records on an expedited 
basis could reasonably be expected to pose an imminent threat to the 
life or physical safety of an individual; or
    (2) There is an urgent need to inform the public about an actual or 
alleged Federal Government activity (this criterion applies only to 
those requests made by a person primarily engaged in disseminating 
information to the public).
    (d) We will respond to your request for expedited processing within 
10 calendar days of our receipt of your request to expedite. If we 
grant your request, the HHS OpDiv or StaffDiv responsible for the 
review of the requested records will process your request as a 
priority, and it will be processed as soon as practicable. We will 
inform you if we deny your request for expedited processing and provide 
you with appeal rights. If you decide to appeal that denial, we will 
expedite our review of your appeal.


Sec.  5.28  How does HHS respond to my request?

    (a) The appropriate FOIA Officer will send you a response informing 
you of our release determination, including whether any responsive 
records were located, how much responsive material was located, whether 
the records are being released in full or withheld in full or in part, 
and any fees you must pay for processing of the request. The HHS FOIA 
Officer may, at their discretion, respond to similar requests or 
requests involving a common subject matter that have been submitted to 
multiple HHS OpDivs or StaffDivs, or to other FOIA requests which are 
deemed appropriate for a Departmental response.
    (b) If we deny any part of your request, our response will explain 
the reasons for the denial, which FOIA exemptions apply to withheld 
records, and your right to appeal that determination. We will advise 
you of the number of pages withheld or the estimated volume of withheld 
records, unless providing such information would harm an interest 
protected by an applicable FOIA exemption. In order to exhaust your 
administrative remedies, you must file an administrative appeal in 
accordance with Sec.  5.52, before initiating judicial review.
    (c) Records may be withheld in full or in part if any of the nine 
FOIA exemptions apply. If we determine to withhold part of a record 
pursuant to an exemption, we will provide access to reasonably 
segregable non-exempt information contained in the record. On the 
released portion of the record, we indicate where the information has 
been redacted and the exemption(s) we applied, unless including that 
indication would harm an interest the exemption protects. In Subpart C 
of this part, we describe the scope of the exemptions to disclosure 
that may apply to agency records.
    (d) We also may determine that a request does not reasonably 
describe the records sought; the information requested is not a record 
subject to the FOIA; the requested records do not exist, cannot be 
located, or have been destroyed; or that the requested records are not 
readily reproducible in the form or format requested.
    (e) If a request involves a voluminous amount of material or 
searches in multiple locations, we may provide you with interim 
responses if feasible and reasonably possible, releasing the records on 
a rolling basis.
    (f) Copies of records in the format you request will be provided if 
the records already exist in that format or if they are reasonably and 
readily reproducible in the format you request.


Sec.  5.29  How may I request assistance with the FOIA process?

    (a) If you have questions concerning the processing of your FOIA 
request, you should first contact the FOIA Service Center processing 
your request. Additionally, for assistance at any point in the FOIA 
process, you may contact the FOIA Public Liaison at the FOIA Service 
Center processing your request. The FOIA Public Liaison is responsible 
for assisting you to reduce delays, increasing transparency and 
understanding of the status of requests, and assisting to resolve any 
FOIA disputes. Some FOIA Service Centers allow you to check the status 
of your request online. You can find a list of our FOIA Service Centers 
and Public Liaisons at http://www.hhs.gov/foia/contacts/index.html.
    (b) The Office of Government Information Services (OGIS), which is 
part of the National Archives and Records Administration, serves as the 
Federal FOIA ombudsman and assists requesters and agencies to prevent 
and resolve FOIA disputes. You may contact OGIS at the following 
address: National Archives and Records Administration, Office of 
Government Information Services, 8601 Adelphi Road--OGIS, College Park, 
MD 20740-6001, or by email at [email protected], or by telephone at 202-
741-5770 or 1-877-684-6448 (toll free).

Subpart C--Exemptions to Disclosure


Sec.  5.31  What are the reasons records may be withheld?

    While we are committed to providing public access to as many of our 
records as possible, there are instances in which information falls 
within one or more of the FOIA's nine exemptions to disclosure. We 
review all records and weigh and assess all legal and policy 
requirements prior to making a final disclosure determination. A 
description of the scope of the nine FOIA exemptions is provided in 
paragraphs (a) through (i) of this section.
    (a) Exemption 1. Exemption 1 requires our agency to withhold 
records that, as provided by FOIA, are specifically authorized under 
criteria established by an Executive Order to be kept secret in the 
interest of national defense or foreign policy and are in fact properly 
classified pursuant to such Executive Order. When the release of 
certain records may adversely affect U.S. relations with foreign 
countries, we usually consult with officials of those countries or 
officials of the Department of State. Also, we may, on occasion, have 
in our possession records classified by some other agency. We will 
refer your request for such records to the agency that classified them 
and notify you that we have done so.
    (b) Exemption 2. Exemption 2 authorizes our agency to withhold 
records that are solely related to the internal personnel rules and 
practices of an agency.
    (c) Exemption 3. Exemption 3 requires our agency to withhold 
records which are specifically exempted from disclosure by statute 
(other than 5 U.S.C. 552(b)) provided that such statute requires that 
the matters be withheld from the public in such a manner as to leave no 
discretion on the issue; or establishes particular criteria for 
withholding or refers to particular types of matters to be withheld; 
and if enacted after the date of enactment of the OPEN FOIA Act of 
2009, October 28, 2009, specifically cites to 5 U.S.C. 552(b)(3).
    (d) Exemption 4. Exemption 4 requires our agency to withhold trade 
secrets and commercial or financial information that is obtained from a 
person and that is privileged or confidential.
    (1) Trade secrets. A secret, commercially valuable plan, formula, 
process, or device that is used for the making, preparing, compounding, 
or processing of trade commodities and that can be said to be the end 
product of either innovation or substantial effort.
    (2) Commercial or financial information. We will not disclose

[[Page 39011]]

records where the information is ``commercial or financial,'' is 
obtained from a person, and is ``privileged or confidential.''
    (i) Information is ``commercial or financial'' if it relates to 
businesses, commerce, trade, employment, profits, or finances 
(including personal finances). We interpret this category broadly.
    (ii) Information is ``obtained from a person'' if HHS or another 
agency has obtained it from someone who has a commercial or financial 
interest in the information. ``Person'' includes an individual, 
partnership, corporation, association, or public or private 
organization other than an agency. Information is not ``obtained from a 
person'' if it is generated by HHS or another Federal agency. Documents 
prepared by the government can still come within Exemption 4, however, 
if they simply contain summaries or reformulations of information 
supplied by a source outside the government, who retains a commercial 
or financial interest in the information.
    (iii) Information is ``privileged'' if it would ordinarily be 
protected from disclosure in civil discovery by a recognized 
evidentiary privilege, such as the attorney-client privilege or the 
work product privilege. Information may be privileged for this purpose 
under a privilege belonging to a person outside the government, unless 
providing the information to the government rendered the information no 
longer protectable in civil discovery.
    (iv) Information is ``confidential'' if it meets one of the 
following tests:
    (A) Disclosure of information which was provided voluntarily to the 
Government may impair the government's ability to obtain necessary 
information in the future;
    (B) Disclosure of information which was required to be provided to 
the Government will result in a diminution of quality and reliability 
of such information in the future;
    (C) Disclosure would be likely to cause substantial harm to the 
competitive position of the person who submitted the information;
    (D) Disclosure would impair other government interests, such as 
program effectiveness and compliance; or
    (E) Disclosure would impair other private interests, such as an 
interest in controlling availability of intrinsically valuable records, 
which are sold in the market by their owner.
    (3) Designation of certain confidential information. A person who 
submits records to the government may designate part or all of the 
information in such records as exempt from disclosure under Exemption 4 
of the FOIA. The person may make this designation either at the time 
the records are submitted to the government or within a reasonable time 
thereafter. The designation must be in writing. Any such designation 
will expire ten years after the records were submitted to the 
government.
    (4) Predisclosure notification. The procedures in this paragraph 
apply to records on which the submitter has designated information as 
provided in paragraph (d)(3) of this section. They also apply to 
records that were submitted to the government where we have substantial 
reason to believe that information in the records could reasonably be 
considered exempt under Exemption 4. Certain exceptions to these 
procedures are stated in paragraph (d)(5) of this section.
    (i) When we receive a request for such records, and we determine 
that we may be required to disclose them, we will make reasonable 
efforts to notify the submitter about these facts. The notice will 
include a copy of the request, and it will inform the submitter about 
the procedures and time limits for submission and consideration of 
objections to disclosure. If we must notify a large number of 
submitters, we may do this by posting or publishing a notice in a place 
where the submitters are reasonably likely to become aware of it.
    (ii) The submitter has 10 working days from receipt of the notice 
to object to disclosure of any part of the records and to state all 
bases for its objections. FOIA Offices in HHS and its organizational 
components may extend this period as appropriate and necessary.
    (iii) We review and consider all objections to release that we 
receive within the time limit. Any information provided by a submitter 
under this provision may itself be subject to disclosure under the 
FOIA. If a submitter does not respond to our agency within the 
specified time period, we will process the FOIA request without the 
submitter's input. If we decide to release the records, we inform the 
submitter in writing, along with our reasons for the decision to 
release. We include with the notice a description of the information to 
be disclosed or copies of the records as we intend to release them. We 
also inform the submitter that we intend to release the records within 
5 working days after the date of the notice, unless ordered to do 
otherwise by a court of competent jurisdiction. We do not consider any 
information we receive after the date of a disclosure decision.
    (iv) When a requester files suit under the FOIA to obtain records 
covered by this paragraph, we will promptly notify the submitter.
    (v) If the requester files a lawsuit under the FOIA for access to 
records submitted to HHS, we promptly notify the submitter.
    (vi) We will notify the requester in these circumstances:
    (A) When we notify a submitter that it may be required to disclose 
information under the FOIA, we will also notify the requester that 
notice and opportunity to comment are being provided to the submitter;
    (B) When the agency notifies a submitter of a final disclosure 
decision under the FOIA, and;
    (C) When a submitter files a lawsuit to prevent the disclosure of 
the information.
    (5) Exceptions to predisclosure notification. The notice 
requirements in paragraph (d)(4) of this section do not apply in the 
following situations:
    (i) We determine that we should withhold the information under a 
FOIA exemption;
    (ii) The information has been lawfully published or made available 
to the public
    (iii) We are required by a statute (other than the FOIA), or by a 
regulation issued in accordance with the requirements of Executive 
Order 12600, to disclose the information; or
    (iv) The designation made by the submitter appears obviously 
frivolous. However, in such a case, the agency must provide the 
submitter with written notice of any final disclosure determination and 
intent to release, within five working days prior to the specified 
disclosure date. We will notify the submitter as referenced in Sec.  
5.31(d)(4)(iii).
    (e) Exemption 5. Exemption 5 protects inter-agency or intraagency 
memorandums or letters which would not be available by law to a party 
other than an agency in litigation with the agency. This exemption 
extends only those documents that are normally privileged in the civil 
discovery context. Some of the most commonly applicable privileges are 
described in the following paragraphs.
    (1) Deliberative process privilege. This privilege protects 
predecisional deliberative communications. A document is predecisional 
if it is generated before the adoption of an agency policy, and does 
not necessarily have to point specifically to an agency final decision. 
The purpose of the privilege is to prevent injury to the quality of the 
agency decision making process by encouraging open and frank

[[Page 39012]]

internal policy discussions, by avoiding premature disclosure of 
policies not yet adopted, and by avoiding the public confusion that 
might result from disclosing reasons that were not in fact the ultimate 
grounds for an agency's decision. Purely factual material in a 
deliberative document is within this privilege only if it is 
inextricably intertwined with the deliberative portions so that it 
cannot reasonably be segregated, if it would reveal the nature of the 
deliberative portions, or if its disclosure would in some other way 
make possible an intrusion into the decisionmaking process. The 
privilege continues to protect predecisional communications even after 
a decision is made; additionally, predecisional, deliberative 
communications will remain protected even if a final decision is not 
achieved.
    (2) Attorney work product privilege. This privilege protects 
documents prepared by or for an agency, or by or for its legal 
representatives in anticipation of litigation or for trial. It includes 
documents prepared for purposes of administrative adjudications as well 
as court litigation. It includes documents prepared by program offices 
and may include documents prepared by agency contractors in the 
authorized performance of agency duties, if requested by an attorney in 
anticipation of litigation. It includes factual material in such 
documents as well as material revealing opinions and tactics. Finally, 
the privilege continues to protect the documents even after the 
litigation is closed.
    (3) Attorney-client privilege. This privilege protects confidential 
communications between a lawyer and an employee or agent of the 
government where there is an attorney-client relationship between them 
(typically, where the lawyer is acting as attorney for the agency and 
the employee is communicating on behalf of the agency) and where the 
employee has communicated information to the attorney in confidence in 
order to obtain legal advice or assistance.
    (f) Exemption 6. Exemption 6 protects information about individuals 
in personnel and medical files and similar files when the disclosure of 
such information would constitute a clearly unwarranted invasion of 
personal privacy. This exemption authorizes us to withhold records 
about individuals if disclosure would constitute a clearly unwarranted 
invasion of their personal privacy. We utilize a balancing test in 
deciding whether to release records to you that contain personal or 
private information about someone else; that is, we weigh the 
foreseeable harm of invading that person's privacy against the public 
benefit that would result from the release.
    (g) Exemption 7. Exemption 7 authorizes our agency to withhold 
records or information compiled for law enforcement purposes, but only 
to the extent that the production of such law enforcement records or 
information would cause the following harm(s):
    (i) Could reasonably be expected to interfere with enforcement 
proceedings;
    (ii) Would deprive a person of a right to a fair trial or an 
impartial adjudication;
    (iii) Could reasonably be expected to constitute an unwarranted 
invasion of personal privacy;
    (iv) Could reasonably be expected to disclose the identity of a 
confidential source, including a state, local, or foreign agency or 
authority, or any private institution which furnished information on a 
confidential basis, and, in the case of a record or information 
compiled by a criminal law enforcement authority in the course of a 
criminal investigation, or by an agency conducting lawful national 
security intelligence investigation, information furnished by a 
confidential source;
    (v) Would disclose techniques and procedures for law enforcement 
investigations or prosecutions, or would disclose guidelines for law 
enforcement investigations or prosecutions, if such disclosure could 
reasonably be expected to risk circumvention of the law; or
    (vi) Could reasonably be expected to endanger the life or physical 
safety of any individual.
    (h) Exemption 8. Exemption 8 authorizes the withholding of records 
that are contained in or related to examination, operating, or 
condition reports prepared by, on behalf of, or for the use of an 
agency responsible for the regulation or supervision of financial 
institutions.
    (i) Exemption 9. Exemption 9 permits the withholding of geological 
and geophysical information and data, including maps, concerning wells.


Sec.  5.32  Records not subject to the requirements of the FOIA--law 
enforcement exclusions.

    Under the FOIA, there is special protection for three narrow 
categories of law enforcement and national security records. The 
provisions protecting those records are known as ``exclusions.'' These 
exclusions expressly authorize Federal law enforcement agencies, under 
these exceptional circumstances, to treat the records as not subject to 
the requirements of the FOIA, and are further described as follows:
    (a) The first exclusion protects the existence of an ongoing 
criminal law enforcement investigation when there is reason to believe 
that the subject of the investigation or proceeding is not aware of its 
pendency and disclosure of the existence of records could reasonably be 
expected to interfere with enforcement proceedings.
    (b) The second exclusion is limited to criminal law enforcement 
agencies and protects the existence of informant records when the 
informant's status has not been officially confirmed.
    (c) The third exclusion is limited to the Federal Bureau of 
Investigation and protects the existence of foreign intelligence or 
counterintelligence, or international terrorism records when the 
existence of such records is classified.
    (d) Should an HHS OpDiv or StaffDiv maintain records which are 
subject to a FOIA exclusion, and consider employing an exclusion or 
have a question as to the implementation of an exclusion, the OpDiv or 
StaffDiv will consult with the Office of Information Policy, U.S. 
Department of Justice.
    (e) Because records falling within an exclusion are not subject to 
the requirements of the FOIA, should any HHS OpDiv or StaffDiv maintain 
such excluded records, the OpDiv or StaffDiv will limit its response to 
those records that are subject to the FOIA.

Subpart D--Fees


Sec.  5.41  General information on fees for all FOIA requests.

    (a) We generally assume that when you request records you are 
willing to pay the fees we charge for services associated with your 
request. As referenced in Sec.  5.42(c), you may specify a limit on the 
amount you are willing to spend. We will notify you if it appears that 
the fees will exceed the limit and ask whether you nevertheless want us 
to proceed with the search.
    (b) If you have failed to pay FOIA fees in the past, we will 
require you to pay your past due bill and we may also require you to 
pay the anticipated fee before we begin processing your current 
request. If we estimate that your fees may be greater than $250, we 
also may require advance payment or a deposit before we begin 
processing your request. If you fail to make an advance payment within 
10 working days after the date of our fee letter, we will close the 
request.
    (c) We may charge interest on unpaid bills beginning on the 31st 
calendar day following the day the FOIA fee invoice was sent. We may 
assess interest, administrative costs, and penalties for overdue FOIA 
fee costs.

[[Page 39013]]

    (d) If we determine that you (either acting alone or with a group 
of requesters) are breaking down a single request into a series of 
requests in order to avoid or reduce fees, we may aggregate all of 
these requests when calculating the fees. In aggregating requests, we 
may consider the subject matter of the requests and whether the 
requests were filed close in time to one another.
    (e) If, in the course of negotiating fees, you do not respond to 
the agency within 10 working days of our last communication, your 
request will be closed.
    (f) We may stop the processing of your request, if necessary, to 
clarify fee issues with you, and to confirm your willingness to pay 
applicable fees. Fee related issues may arise sequentially over the 
course of processing a request, and the FOIA allows agencies to stop 
the processing time as many times as necessary in order to clarify 
issues regarding fee assessment and willingness to pay fees.


Sec.  5.42  What fee policies apply to HHS records?

    (a) We may charge search fees even if the records are exempt from 
disclosure, or if we do not find any responsive records during our 
search.
    (b) We do not send an invoice to requesters if processing fees are 
less than $25.
    (c) If estimated search or review fees exceed $250, we will contact 
you. If you have specified a different limit that you are willing to 
spend, we will contact you only if we estimate the fees will exceed 
that specified amount.


Sec.  5.43  What is the FOIA fee schedule for obtaining records?

    In responding to FOIA requests for records, we charge the following 
fees, where applicable, unless we have given you a reduction or waiver 
of fees. Under the FOIA, fees are three-tiered, and the hourly charge 
is determined by the classification and grade level of the employee 
performing the search and review. The current FOIA fee schedules can be 
found on the HHS.gov Web site at http://www.hhs.gov/foia/fees/index.html.
    (a) Search fees--(1) Manual searches. Fees will be assessed to 
search agency files and records in both hardcopy and electronic format. 
Such fees will be at the rate or rates for the classification of the 
employee(s) performing the search, as established in this section.
    (2) Computer searches. We base the fees for computer searches on 
the actual cost to our agency of operating the computer and the salary 
of the operator.
    (b) Review fees. (1) We charge review fees for time we spend 
examining documents that are responsive to a request to determine 
whether we must apply any FOIA exemptions to withhold information. 
Review time includes processing any record for disclosure (i.e., doing 
all that is necessary to prepare the record for disclosure), including 
redacting the record and marking the appropriate FOIA exemptions. We 
charge review fees even if we ultimately are unable to disclose a 
record.
    (2) We do not charge review fees for time we spend resolving 
general legal or policy issues regarding the application of exemptions. 
However, we do charge review fees for time we spend obtaining and 
considering any formal objection to disclosure made by a confidential 
commercial information submitter.
    (c) Duplication fees--(1) Photocopying standard-sized pages. The 
current charge for photocopying records can be found on the HHS.gov Web 
site at http://www.hhs.gov/foia/fees/index.html.
    (2) Reproduction of electronic records. We charge you for our 
direct costs for staff time and to organize, convert, and format data 
for release, per requester instructions, and for printouts or 
electronic media necessary to reproduce electronic records requested 
under the FOIA. We will attempt to provide records in the format you 
sought, if the records are reasonably and readily reproducible in the 
requested format.
    (3) Copying other media. We will charge you the direct cost of 
copying other media.
    (d) Mailing and special delivery fees. We release records by United 
States Postal Service or, when appropriate, by electronic means, such 
as electronic mail or web portal. If a requester seeks special 
delivery, such as overnight shipping, we reserve the right to pass on 
the actual costs of special delivery to the requester. Requesters may 
provide their mailing account and billing information to the agency, so 
that they may pay directly for special delivery options.
    (e) Certification of records. The FOIA does not require agencies to 
certify records as true copies. We may elect, as a matter of 
administrative discretion, to certify records upon request; however, 
such a request must be submitted in writing. Further, we will only 
certify as true copies records that have not left the agency's chain of 
custody. The charge for certification is $25.00 per record certified.


Sec.  5.44  How does HHS calculate FOIA fees for different categories 
of requesters?

    (a) If you are a commercial use requester, we charge you fees for 
searching, reviewing, and duplicating responsive records.
    (b) If you are an educational or noncommercial scientific 
institution requester, or a member of the news media, you are entitled 
to search time, review time, and up to 100 pages of duplication (or the 
cost equivalent for other media) without charge. We charge duplication 
fees after the first 100 pages (or its cost equivalent).
    (c) If you do not fall into either of the categories in paragraphs 
(a) and (b) of this section, and are an ``other requester,'' you are 
entitled to two hours of free search time, up to 100 pages of 
duplication (or the cost equivalent of other media) without charge, and 
you will not be charged for review time. We may charge for search time 
beyond the first two hours and for duplication beyond the first 100 
pages (or its cost equivalent).
    (d) We shall not assess search fees (or duplication fees for 
educational, scientific and media requesters) if the agency fails to 
comply with any time limit under 5 U.S.C. 552(a)(6) in processing that 
request; unless unusual or exceptional circumstances apply.


Sec.  5.45  How may I request a fee waiver?

    (a) We will waive or reduce your fees for HHS records only if your 
request meets both of the following criteria:
    (1) The request is in the public interest (i.e., the information is 
likely to contribute significantly to public understanding of the 
operations or activities of the Government); and
    (2) The request is not primarily in your commercial interest.
    (b) To be eligible for a fee waiver or reduction you must explain:
    (1) How the records you are requesting pertain to the operations 
and activities of the Federal Government. There must be a clear 
connection between the identifiable operations or activities of the 
Federal Government and the subject of your request;
    (2) How the release will reveal meaningful information that the 
public does not already know about Federal Government activities. 
Disclosing information that is already in the public domain, in either 
the same or a substantially identical form, does not add anything new 
to the public's understanding of Government activities;
    (3) How disclosure to you will advance public understanding of the 
issue;
    (4) How your expertise or understanding of the requested records

[[Page 39014]]

as well as your ability and intention will effectively convey 
information to the public. We ordinarily presume that a representative 
of the news media satisfies this consideration;
    (5) How you intend to disseminate the requested information to a 
broad spectrum of the public; and
    (6) How disclosure will lead to a significantly greater 
understanding of the Government by the public.
    (c) After reviewing your request and determining that there is a 
substantial public interest in release, we also determine if the 
request primarily furthers your commercial interests. If it does, you 
are not eligible for a fee waiver.
    (d) You should ask for waiver or reduction of fees when you first 
submit your request to HHS, and should address the criteria referenced 
in this section.
    (e) We may waive (either partially or in full) or reduce fees for 
records in additional circumstances as a matter of administrative 
discretion.

Subpart E--Appeals


Sec.  5.51  When may I appeal HHS's FOIA determination?

    In order to fully exhaust all of your administrative remedies, you 
must file an appeal of an adverse agency determination. You may appeal 
when there is an adverse determination, including:
    (a) Refusal to release a record, either in whole or in part;
    (b) Determination that a record does not exist or cannot be found;
    (c) Determination that the record you sought was not subject to the 
FOIA;
    (d) Denial of a request for expedited processing;
    (e) Denial of a fee waiver request; or
    (f) Fee category determination.


Sec.  5.52  How do I file an appeal?

    (a) You have the right to appeal an adverse agency determination of 
your FOIA request.
    (b) You may submit your appeal via mail or electronically. All 
appeals must be in writing and received by HHS within 45 calendar days 
from the date of our final determination letter.
    (1) Please send your appeal to the review official at the address 
provided in your denial letter. If you are unsure who is the 
appropriate review official, please contact the FOIA Service Center 
that processed your request to obtain that information.
    (2) The addresses to mail FOIA appeals for CMS, the PSC and OS are, 
respectively: Centers for Medicare & Medicaid Services, Attn: Principal 
Deputy Administrator, Room C5-16-03, 7500 Security Boulevard, 
Baltimore, MD 21244; U.S. Department of Health and Human Services 
(PSC), Deputy Agency Chief FOIA Officer, Office of the Assistant 
Secretary for Public Affairs, 5600 Fishers Lane, Room 19-01, Rockville, 
MD 20857; U.S. Department of Health and Human Services, Deputy Agency 
Chief FOIA Officer, Office of the Assistant Secretary for Public 
Affairs, Room 729H, 200 Independence Avenue SW., Washington, DC 20201. 
Additionally, information can be found at the following online 
locations for CMS, PSC, and OS: https://www.cms.gov/Regulations-and-Guidance/Legislation/FOIA/filehow.html; http://www.psc.gov/psc_foia/guide.html; and http://www.hhs.gov/foia/FOIA%20Appeals/index.html.
    (3) For appeals submitted via mail, you should mark both your 
letter and envelope with the words ``FOIA Appeal'' and include your 
FOIA request tracking number, a copy of your initial request, and our 
final determination letter.
    (c) Your appeal should clearly identify the agency determination 
that is being appealed. It would be helpful if you provide specific 
reasons explaining why you believe the agency's adverse determination 
should be reconsidered.


Sec.  5.53  How does HHS process appeals?

    (a) We respond to your appeal within 20 working days after the 
appeal official designated in your appeal letter receives it. If, 
however, your appeal is based on a denial of a request for expedited 
processing, we will act on your appeal of that decision expeditiously. 
Before making a decision on an appeal of an adverse determination, the 
designated review official will consult with the Office of the General 
Counsel. Also, the concurrence of the Office of the Assistant Secretary 
for Public Affairs is required in all appeal decisions, including those 
on fees. When the review official responds to an appeal, that 
constitutes the Department's final action on the request.
    (b) If we reverse or modify the initial decision, we will inform 
you in writing and, if applicable, reprocess your request. If we do not 
change our initial decision, we will respond in writing to you, explain 
the reasons for the decision, set out any FOIA exemptions that apply, 
and inform you of the provisions for judicial review. If a requester 
files a FOIA lawsuit in reference to an appeal, we will cease 
processing the appeal.


Sec.  5.54  What avenues are available to me if I disagree with HHS's 
appeal decision?

    (a) In our response letter, we notify you of your right to seek 
judicial review of an adverse determination as set forth in the FOIA at 
5 U.S.C. 552(a)(4)(B). If you wish to seek judicial review of any 
adverse determination, you must first appeal it administratively as 
described in this subpart.
    (b) We also inform you that the Office of Government Information 
Services (OGIS) offers mediation services to resolve disputes between 
FOIA requesters and Federal agencies as a non-exclusive alternative to 
litigation. As referenced in Sec.  5.29(b) you may contact OGIS via 
mail, email, or telephone for assistance.

Subpart F--Records Retention


Sec.  5.61  How does HHS retain FOIA records?

    We will preserve records created in administering the Department's 
Freedom of Information program until disposition is authorized under an 
applicable General Records Schedule or other records schedule duly 
approved by the Archivist of the United States.

    Dated: June 7, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-13994 Filed 6-14-16; 8:45 am]
 BILLING CODE 4150-25-P