[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Rules and Regulations]
[Pages 74930-74949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25684]


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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: Final rule.

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SUMMARY: This rule amends the Department of Health and Human Services 
(HHS's) Freedom of Information Act (FOIA) regulations. The regulations 
have been revised in order to incorporate changes made to the FOIA by 
the Electronic FOIA Act of 1996 (E-FOIA Act), the Openness

[[Page 74931]]

Promotes Effectiveness in our National Government Act of 2007 (OPEN 
Government Act), and the FOIA Improvement Act of 2016 (FOIA Improvement 
Act). Additionally, the regulations have been 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.

DATES: This rule is effective on November 28, 2016.

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: HHS published a proposed rule to amend its 
FOIA regulations for public comment in the Federal Register at 81 FR 
39003 on June 15, 2016. The comment period ended on August 15, 2016. In 
total, we received 10 public comments in response to the proposed rule. 
We have given due consideration to each of the comments we received, 
and, in response, we have made several modifications to the proposed 
rule. These modifications include clarifying, revising, expanding, or 
adding various provisions, withdrawing provisions, and making minor 
technical edits. We have addressed the substantive comments that we 
received in narrative form below; grouped by the section the comment 
corresponds to, as located in the proposed rule.

Purpose (Sec.  5.1)

    One commenter recommended removing a provision that we originally 
proposed in Sec.  5.1(b)(1) concerning records that are subject to a 
statutorily-based fee schedule program. The commenter interpreted this 
provision to suggest that we would withhold records in response to a 
FOIA request simply because a separate statute provided for charging 
fees for those records. In order to help clarify the meaning of that 
provision, the commenter's recommendation has been accepted and the 
proposed provision has been removed. An additional provision relating 
to records that are subject to other statutes specifically providing 
for fees has been added at Sec.  5.52(f). In addition to the language 
in Sec.  5.1(b)(1) concerning records that are subject to a 
statutorily-based fee schedule program, we have also removed the 
language concerning Sec. Sec.  5.1(b)(2), (3) and (5), as we consider 
the provisions of Sec.  5.2 to adequately address proactive disclosures 
and the provisions of Sec.  5.5 and Sec.  5.22 to adequately address 
the interrelationship between the FOIA and the Privacy Act and how to 
make a first-party request.

Presumption of Openness and Proactive Disclosures (Sec.  5.2)

    Three commenters suggested revising the language of this section to 
more closely conform to the provisions of the FOIA Improvement Act, 
which codified the presumption of openness into the statute. This 
recommended change has been made and the rule reflects the statutory 
language at 5 U.S.C. 552(a)(8).
    Two commenters suggested that we add language concerning proactive 
disclosures to this section. One of these commenters provided suggested 
language, which included a reference to two types of records that 
government agencies are required to make available to the public in an 
electronic format pursuant to the FOIA Improvement Act and 5 U.S.C. 
552(a)(2)(D). Another commenter suggested that we consider the 
Department of Justice's FOIA regulation and government-wide guidance 
when drafting language on the subject. After considering these 
comments, we have added additional language to this section describing 
the responsibility of HHS Operating and Staff Divisions to proactively 
make certain records available to the public under the FOIA. This 
includes describing the responsibility for HHS Operating and Staff 
Divisions to identify additional records of interest to the public that 
are appropriate for public disclosure and referencing frequently 
requested records, which the rule defines in Sec.  5.3 to include 
records, regardless of form or format, that have been released to any 
person and have been requested three or more times. This conforms with 
the proactive disclosure provisions of the FOIA, as amended by the FOIA 
Improvement Act.
    One commenter suggested that requesters who make requests for 
records that ultimately become frequently requested records should have 
the option to receive credit for their FOIA requests, or, in the event 
that that seems like too much work, the Department should simply always 
give credit. We decline to accept the commenter's suggestion. There is 
no provision in the FOIA requiring agencies to give ``credit'' to 
requests for records that ultimately become frequently requested 
records. There also does not appear to be any policy rationale behind 
this suggestion. The purpose of the FOIA is not to provide ``credit'' 
to individuals or entities that make requests. Rather, it is to ensure 
an informed citizenry and inform the public about the operations and 
activities of the government.
    One commenter, in connection with the requirements that we make 
certain records available proactively for public inspection in an 
electronic format and make available in an electronic format frequently 
requested records, suggested that we properly track and make available 
Public Use Files (PUFs) and ensure that they are adequately maintained. 
In addition, the commenter suggested we proactively track and publish 
score cards for PUF release reliability alongside data about FOIA 
performance. This comment is outside the scope of the rule. The purpose 
of this rule is to provide guidelines for the processing of agency 
records under the FOIA. The rule does not specify how we will treat 
specific category of records unless those categories are specifically 
delineated in the FOIA statute.
    One commenter suggested that the Department should use the systems 
it has to proactively release information pursuant to 5 U.S.C. 
552(a)(2) to highlight types of records that HHS is obligated to have 
but could not locate in response to a FOIA request. After reviewing 
this comment, we have decided not to accept the suggestion. The purpose 
of 5 U.S.C. 552(a)(2) is to make certain categories of records 
available to the public automatically and without waiting for a FOIA 
request. Our main goal in implementing this provision of the FOIA is to 
determine which records we must make publicly available (including 
frequently requested records), to identify additional records of 
interest to the public that are appropriate for public disclosure, and 
to post and index such records.
    One commenter stated that HHS should track Structured Query 
Languages (SQLs) used to respond to data FOIA requests. The commenter 
believes these should be tracked to make sure that PUF files released 
as a frequently requested record are consistent over time even after 
contractors or personnel change. The commenter also wanted the SQL and 
schema definitions to be provided with the response to the FOIA 
request/data result and if software was used, that should be provided 
with the data too. This comment is outside the scope of the rule. The 
rule does not specify how we will treat specific category of records 
unless those categories are specifically delineated in the FOIA 
statute.

Definitions (Sec.  5.3)

    One commenter suggested revising the definition of ``educational 
institution'' to include a student who

[[Page 74932]]

makes a request in furtherance of their coursework or other school-
sponsored activities, which reflects a recent development in the case 
law. The suggested change has been accepted.
    In order to comport with a recent development in the case law, two 
commenters suggested removing the following line from the definition of 
``representative of the news media'': ``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.'' We have accepted 
this suggestion. Another commenter also had a concern with this 
language, but that comment is now moot since the language has been 
removed.
    One commenter recommended including a comprehensive list of 
entities that would qualify as a ``representative of the news media'' 
instead of citing examples such as television, radio stations, and 
periodicals. The commenter noted that modern journalism has moved 
online. We have decided to reject the commenter's suggestion to include 
a comprehensive list of entities that would qualify as 
``representatives of the news media.'' Such a list would be difficult 
to devise and could become quickly outdated, given the ever-changing 
media landscape. We do note, however, that the rule acknowledges the 
presence of online media and makes reference to ``online publications 
that disseminate news''.
    One commenter thought that the following wording used to describe 
the term ``representative of the news media'' was unclear: ``We do not 
consider requests for records that support the news-dissemination 
function of the requester to be a commercial use.'' In response to this 
comment, we do not believe that this wording requires additional 
clarification. This wording was derived from the Uniform Freedom of 
Information Fee Schedule and Guidelines published by the Office of 
Management and Budget (OMB). The OMB has policy-making responsibility 
for issuing fee guidance, and we defer to the OMB for any further 
interpretation of this wording.
    One commenter suggested that the rule include performance metrics 
to evaluate the Chief FOIA Officer and the Deputy Chief FOIA Officer 
and that these metrics be based on objective measures of external 
collaboration (e.g., number of emails answered, average response time 
to answer FOIA requester questions, etc.). While we believe strongly in 
providing good customer service and being held accountable for 
providing timely responses to FOIA requests, we believe the mechanisms 
to achieve these goals are already in place. Requesters can seek 
assistance with the processing of their requests by contacting the 
appropriate FOIA Public Liaison at the FOIA Requester Service Center 
processing their request. Requesters can also seek assistance with 
their FOIA request through the services provided by the Office of 
Government Information Services (OGIS). Moreover, each year we submit 
to the Department of Justice and make available to the public two 
reports evaluating the Department's performance on FOIA: the Annual 
FOIA Report and the Chief FOIA Officer Report. The Annual FOIA Report 
contains detailed statistics on the numbers of requests received and 
processed by the Department, the time taken to respond, and the outcome 
of each request, as well as many other vital statistics regarding the 
administration of the FOIA at the Department. The Chief FOIA Officer 
Report includes detailed descriptions of the steps taken by the 
Department to improve FOIA compliance and transparency. Together, these 
reports provide the public with an accurate representation of the 
Department's performance on FOIA.
    One commenter suggested making a grammatical change to the first 
sentence of the definition of the term ``FOIA request'' and suggested 
removing the second sentence of the definition because it does not 
enhance the reader's understanding of the meaning of the term. The 
commenter also thought that the second sentence of the definition might 
restrict the Department's ability to communicate with requesters. After 
considering this comment, we have made the suggested grammatical change 
to the first sentence of the definition and removed the second 
sentence.
    Two commenters noted that we included a link in the definition of 
``Freedom of Information (FOIA)'' that is no longer active and 
suggested that we either remove the link or update it. In response to 
these comments, we have updated the link. The updated link includes the 
current text of the FOIA.
    One commenter suggested that the term ``Freedom of Information 
Officer'' be replaced with the term ``Freedom of Information Act 
Officer'' for the sake of consistency. The commenter noted that the 
word ``act'' is used in the titles of the Chief Freedom of Information 
Act Officer and the Deputy Chief Freedom of Information Act Officer and 
that the term ``Freedom of Information Officer'' has been shortened to 
``FOIA Officer'' in Sec. Sec.  5.27(b) and 5.28(a). After considering 
this comment, we have decided to accept the suggestion and have 
replaced the term ``Freedom of Information Officer'' with the term 
``Freedom of Information Act Officer''.
    One commenter suggested that the term ``frequently requested 
records'' be modified to include records that have been released to any 
person under the FOIA and that have been requested 3 or more times. The 
FOIA Improvement Act requires federal agencies to make this category of 
records available to the public in an electronic format. In accordance 
with the FOIA Improvement Act, we have amended the term ``frequently 
requested records'' as suggested.
    One commenter recommended changes to the definition of the term 
``submitter''. The commenter suggested clarifying that a person or 
entity that provides financial information qualifies as a submitter 
under the definition. The commenter also recommended adding language to 
the definition stating that a federal agency cannot be considered a 
submitter for the purposes of this rule. After considering this 
comment, the definition of the term submitter has been amended to 
include persons or entities that provide financial information to the 
agency. We have also included language in the definition stating that 
Federal government entities do not qualify as submitters.

Who can file a FOIA request? (Sec.  5.21)

    One commenter noted that two of the three sentences in the section 
state that federal agencies may not submit FOIA requests; the commenter 
thought that one statement to that effect would suffice. At the 
recommendation of the commenter, the second sentence in this section 
has been removed. The revised section only has one sentence stating a 
federal agency may not submit FOIA requests.

How does HHS process my FOIA request? (formerly Sec.  5.25)

    One commenter noted that in Sec.  5.25(b)(1)(iii) we referred to a 
``requestor'' but throughout the rest of the rule, we referred to a 
``requester''. In order to be consistent, we will use ``requester'' for 
all references to the term.
    Two commenters expressed concern with the criteria set forth in 
Sec.  5.25(b)(1) for considering a request perfected and the amount of 
time provided in Sec.  5.25(b)(2) for a requester to respond to a 
request to perfect their request. With regard to Sec.  5.25(b)(1), both 
commenters noted that the FOIA statute states that the twenty-working-
day statutory response period begins to run when the request is 
received by the responsible FOIA office, but not later than ten days 
after it is received by an HHS

[[Page 74933]]

component designated to receive requests. Section 5.25(b)(1) has been 
amended at the recommendation of the commenters and in order to comply 
with the requirements of 5 U.S.C. 552(a)(6)(A). In addition, one of the 
commenters considered the contents of Sec.  5.25(b)(1) to be contrary 
to the FOIA statute itself and recommended that the provision be 
removed from the rule in its entirety. In the view of the commenter, 
the provision added additional requirements to the FOIA that were not 
authorized by law. We disagree with this comment. The FOIA requires 
requesters to satisfy two conditions when submitting a FOIA request: 
that the request reasonably describes the records sought and that it is 
made in accordance with agency's published rule setting forth the 
procedures for filing a FOIA request. If a requester fails to satisfy 
these conditions, Sec.  5.25(b) requires an Operating Division or Staff 
Division to attempt to contact the requester and inform him or her of 
what additional information is needed to meet the requirements of the 
FOIA and this rule. This includes attempts to contact the requester in 
order to reformulate or modify a request in cases where we do not 
consider the records sought to be reasonably described. In addition, in 
instances where we close a request because of a failure to reasonably 
describe the records sought, the requester will be given administrative 
appeal rights to challenge the decision since this is an adverse 
determination. Finally, although such a requirement was legally 
permissible, we have decided to make it easier for requesters to 
perfect their requests by eliminating the requirement that, in order to 
perfect, a requester agree to pay all or an established amount of 
applicable fees or request a fee waiver. We do, however, encourage 
requesters to include such information in their requests and make 
reference to that suggestion in Sec.  5.22.
    As it relates to Sec.  5.25(b)(2), the two commenters expressed 
concern with the amount of time requesters were provided with to 
respond to a request to perfect their requests. One commenter claimed 
that there was no authorization in the FOIA for an agency to 
unilaterally ``administratively close'' a FOIA request; that an agency 
can only grant a request in full or in part or deny it; and that Sec.  
5.25(b)(2) should be removed in its entirety. In the alternative, the 
commenter suggested affording the requester no less than 30 days to 
respond to a request to perfect their request in order to ensure that 
they have sufficient time to respond. The second commenter thought that 
requesters should be given at least 20 working days to respond to 
communications from the agency, and if the agency takes more than 
twenty working days from the date of the request to initiate 
communication with the requester, the requester should receive the same 
amount of time to respond to the agency. The second commenter also 
thought the agency should be required to make at least three good-faith 
efforts to contact a requester by various forms of communication (mail, 
email, telephone), if a communication goes unanswered because it is 
returned as undeliverable. In response to these comments, we have 
increased the amount of time requesters are provided with to respond to 
a request to perfect their request from ``at least 10 working days'' to 
``at least 20 working days''. We believe that this provides requesters 
with a reasonable amount of time to review the request to perfect, 
conduct any necessary research, and respond to the agency. In instances 
where a communication goes unanswered because it is returned as 
undeliverable, we will attempt to reach the requester using any 
alternative contact information provided before administratively 
closing the request. However, we do not think it is necessary to state 
the number of times we will attempt to contact a requester before 
administratively closing the request. Finally, we disagree with the 
comment suggesting that agencies do not have a right to 
administratively close a request. The FOIA specified two requirements 
for an access request: It must reasonably describe the records being 
sought and it must be made in accordance with published rules stating 
the time, place, fees (if any), and procedures to be followed. If a 
requester fails to satisfy these conditions, the rule requires HHS to 
attempt to contact the requester to seek clarification and provides the 
requester with a reasonable amount of time to respond. If a requester 
does not respond to communication within the specified timeframe, it is 
reasonable to deny the request and administratively close it because of 
a failure to reasonably describe the records sought or make the request 
in accordance with the published rules. Such a provision is found in a 
number of agency FOIA regulations throughout the government including 
the regulations of four other cabinet-level departments. Therefore, we 
decline to accept the comment.
    The same two commenters expressed concern with the amount of time 
requesters were provided with in Sec.  5.25(c) to respond to a request 
to respond to requests for additional information or clarification 
regarding the specifics of a request or fee assessment. In response to 
these comments and in order to provide requesters with a reasonable 
amount of time to respond, we have increased the amount of time to 
respond to a request for additional information or clarification 
regarding the specifics of a request or fee assessment from ``at least 
10 working days'' to ``at least 20 working days''. The commenters also 
expressed concern with the language in Sec.  5.25(c) stating ``[s]hould 
you not answer any correspondence, or should the correspondence be 
returned undeliverable, we reserve the right to administratively close 
the FOIA request.'' The concerns expressed about this provision were 
the same as those stated for Sec.  5.25(b)(2), namely that the agency 
should be required to make at least three good-faith efforts to contact 
a requester by various forms of communication (mail, email, telephone), 
if a communication goes unanswered because it is returned as 
undeliverable, and that there is no authorization in the FOIA for an 
agency to unilaterally administratively close a FOIA request. For the 
same reasons stated with regard to Sec.  5.25(b)(2), we decline to 
accept the comment concerning undeliverable communications. With 
respect to whether the agency has the authority to administratively 
close requests when a communication goes unanswered, we again disagree 
with the comment. If a requester does not respond to communication 
within a reasonable amount of time, we have legitimate reason to 
believe that the requester is no longer interested in pursuing their 
request. Moreover, a provision allowing for the administrative closure 
of requests where a request for additional information or clarification 
goes unanswered is commonly included in a number of agency FOIA 
regulations throughout the government including the regulations of four 
other cabinet-level departments.
    Multiple commenters provided input on Sec. Sec.  5.25(e), (f), and 
(h), which describe the Department's procedures for multitrack 
processing and handling requests that involve unusual circumstances. 
One commenter expressed a concern that Sec.  5.25(h) could be read to 
provide the agency with the authority to provide itself with unlimited 
time to respond to complex FOIA requests. Another commenter requested 
that Sec. Sec.  5.25(e) and (f) be modified to include a commitment to 
provide requesters with an estimated completion date if their request 
is

[[Page 74934]]

placed in the complex processing queue or if unusual circumstances 
exist. Additionally, the commenter recommended that Sec.  5.25(h) be 
modified to require an agency to notify a requester of an expected 
delay because of unusual circumstances and that such a notice should 
provide requesters with an explanation of the unusual circumstances and 
an estimated completion date. The commenter recommended providing such 
a notice prior to having any conversations regarding the scope of the 
request. After considering these comments, the contents of Sec. Sec.  
5.25(e), (f), and (h) have been modified to distinguish requests that 
are placed in the complex processing queue from requests involving 
unusual circumstances and to align these sections with the FOIA 
statute. In cases where unusual circumstances require us to extend the 
processing time by more than 10 working days, we have clarified that 
requesters will have an opportunity to modify the request or arrange an 
alternative time period for processing the original or modified 
request. Finally, with regard to estimated completion dates, we have 
clarified the language of the rule indicating that we will provide 
requesters with an estimated completion date when we notify them of the 
unusual circumstances involved with their request. However, we decline 
to accept the commenter's recommendation to provide an estimated 
completion date for all requests placed in the complex processing 
queue. Such a policy is not required by the FOIA and, while we estimate 
the completion date based on our reasonable judgment as to how long it 
will likely take to complete the request, given the uncertainty 
inherent in establishing any estimate, the estimated completion date 
would be subject to change at any time.
    One commenter recommended giving priority to records and data 
requests that give detailed and accurate information about where to 
find the records in question. The commenter believes that requesters 
who make such requests should be rewarded with cheaper fees and faster 
processing time. Requesters who give detailed and accurate information 
receive a number of benefits under the FOIA and this regulation 
already. First, if a request provides detailed and accurate information 
about where to find the records, there is a strong likelihood that the 
request will be considered perfected and quickly routed for search. 
Second, there is a strong likelihood that it will be unnecessary to 
toll the processing time to clarify the scope of the request if the 
requested records are well-described and we are given accurate 
information about where to find the records in question. Third, if the 
request provides accurate information about where to find the records 
in question, the search can be conducted more quickly which could 
reduce search fees, if those are associated with the request, and it 
could speed up the processing time. Finally, we have adopted multitrack 
processing and place requests on the simple or complex track based on 
the estimated amount of work or time needed to process the request. 
Providing information that helps us locate documents responsive to a 
request makes it more likely that the request will be placed on the 
simple track and processed more quickly. Given these advantages, we do 
not believe it is necessary to provide any additional benefits to 
requesters who provide detailed and accurate information about where to 
find the records in question.
    One commenter suggested that the rule be modified to inform 
requesters that they are entitled to judicial review if the agency does 
not meet statutorily imposed deadlines. The commenter further stated 
that HHS should reference 5 U.S.C. 552(a)(6)(C) in the rule and clarify 
how a requester may exhaust his or her administrative remedies. After 
carefully considering this comment, we decline to adopt the commenter's 
suggested change. The FOIA statute itself already makes clear that a 
failure to comply with the time limits for either an initial request or 
an administrative appeal may be treated as a ``constructive 
exhaustion'' of administrative remedies. Once there has been a 
``constructive exhaustion'', a requester may immediately thereafter 
seek judicial review if he or she wishes to do so. It is unnecessary 
for this rule to simply restate information that is already in the FOIA 
statute concerning the exhaustion of administrative remedies.
    One commenter suggested defining the term ``voluminous'' in Sec.  
5.25(f). In revising the rule, we have removed the term ``voluminous'' 
from the referenced section. The term ``voluminous'' was contained in a 
recitation of the statutory definition of unusual circumstances. Since 
the FOIA statute already contains this information, it was unnecessary 
to include in the rule. However, even if the term ``voluminous'' 
remained in the rule, we do not believe it is appropriate to define it 
here. The term ``voluminous'' can be understood by the plain meaning in 
the statute, legislative intent, and any case law interpreting that 
term.
    One commenter suggested we consider adding subsections that fully 
explain referrals, consultations, and coordination with other federal 
agencies or entities. We have accepted the commenter's suggestion. 
Section 5.25 provides a full explanation of the Department's procedures 
for rerouting of misdirected requests, referrals, consultations, and 
coordination.

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

    One commenter expressed a concern about Sec.  5.26(a). In the view 
of the commenter, the language of this provision suggested that 
estimated completion dates are only provided when a requester asks for 
them. The commenter recommended that we provide estimated completion 
dates whenever a request is first placed in the complex processing 
queue, whenever we determine that an estimated completion date must 
change for a request, or when a requester asks for an update on 
expected completion date, and that the language in this section be 
updated to reflect that. In response to this comment, we have amended 
the language in this section to clarify that we will provide estimated 
completion dates when we notify requesters of any unusual circumstances 
involved with their request and when a requester has asked for an 
estimated completion date. However, we decline to accept the 
commenter's recommendation of providing an estimated completion date 
for any request placed in the complex processing queue or whenever an 
estimated completion date must change for a request. As previously 
stated, while we estimate the completion date based on our reasonable 
judgment as to how long it will likely take to complete the request, 
given the uncertainty inherent in establishing any estimate, the 
estimated completion date would be subject to change at any time.

How do I request expedited processing? (Sec.  5.27)

    Multiple commenters submitted comments concerning the criteria for 
granting expedited processing of FOIA request described in Sec.  
5.27(c). One commenter expressed concern that we did not include the 
need to meet a litigation deadline in an administrative appeal or in a 
court action as a case deemed appropriate for granting expedited 
processing. In the opinion of the commenter, a failure to include this 
policy into the rule would contradict the statute and constitute an 
invalid departure from established agency precedent. The commenter 
expressed

[[Page 74935]]

three specific concerns with the rule as it relates to the omission of 
any express provision to grant expedited processing in cases where the 
information is needed to meet a deadline in litigation. First, the 
commenter believes the proposed rule is in conflict with the FOIA 
statute. The FOIA statute provides for expedited processing ``in other 
situations''. The commenter is of the opinion that this meant Congress 
intended for agencies to make expedited processing available for a 
broader range of FOIA requests than just those defined as serving a 
``compelling need.'' Second, the commenter is under the impression that 
HHS has a longstanding policy of allowing expedited processing in cases 
where the information is needed to meet a deadline in litigation. In 
support of this, the commenter cited a stipulated court order in Home 
Health Line, Inc. v. Health Care Financing Admin., 90-cv-1006-LFO 
(D.D.C.1990), and a notice published by the Centers for Medicare & 
Medicaid Services (CMS) (formerly the Health Care Financing 
Administration (HCFA)), as a stipulation of dismissal and settlement of 
the case, outlining its policy for expedited processing. The notice was 
published at 55 FR 51342 (Dec. 13, 1990). The cited notice includes 
language stating that ``HCFA follows its first-in/first-out practice 
for processing requests except where the requester demonstrates 
exceptional need or urgency.'' 55 FR 51342. The notice further states 
that there are three categories of requester needs which HCFA has 
determined frequently [demonstrate exceptional need of urgency].'' Id. 
One of the three categories of requester needs described in the notice 
is ``where the requester needs the specific records in question to meet 
a deadline in litigation, either in a court or before an administrative 
tribunal.'' Id. The commenter asserted that the agency cannot change 
its policy on expedited processing without violating the court order 
and the conditions of settlement in the Home Health Line, Inc. case. 
Finally, the commenter cited the Administrative Procedure Act to state 
that agencies must both acknowledge and explain the reasons for a 
departure from established policies or precedent. In the opinion of the 
commenter, there is no good reason for the agency to depart from a 
policy of granting expedited processing to meet a litigation deadline 
in an administrative appeal or court. The commenter has particular 
concern because, according to the commenter, under HHS regulations 
governing appeals to the PRRB, FOIA is the only means available to 
hospitals and other providers to obtain relevant and material evidence 
concerning the accuracy of Medicare payment determinations by HHS.
    We reject this comment and will discuss each point in the order it 
was raised by the commenter. First, the commenter is incorrect when 
stating that the rule is in conflict with the FOIA statute because the 
rule does not provide for the expedited processing of requests ``in 
other cases determined by the agency.'' 5 U.S.C. Sec. 
552(a)(6)(E)(i)(II). The plain language of the FOIA statute makes clear 
that the decision to provide for expedited processing ``in other 
cases'' is left to the discretion of the agency and the agency is free 
not to deem any other case appropriate. Second, we acknowledge that CMS 
had a policy of ordinarily granting expedited processing on a variety 
of circumstances, both administrative in nature and in response to 
specific needs stated by a requester, and that this policy was 
published in the Federal Register for the public's benefit. However, at 
the time, HHS had not promulgated any rule with respect to expedited 
processing. This rule now promulgates rules for the entire Department 
providing for expedited processing of requests for records and 
supersedes the guidance CMS published at 55 FR 51342. Finally, while 
the adopted regulations do not represent a change in policy for the 
whole Department, we acknowledge that the only circumstance in CMS's 
policy which we have chosen to retain in this rule is when 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. We believe that this change to CMS's policy is necessary 
to establish fairness in the FOIA process. When granting expedited 
processing, we must consider the interest of all requesters in having 
their requests treated equally. We must also bear in mind that whenever 
we grant expedited processing to one requester, other requesters 
waiting patiently in line will have to wait longer for a response. As a 
result, the Department must only grant expedited processing in truly 
exceptional circumstances. The basic purpose of FOIA is to ensure that 
there is an informed citizenry, which is vital to the functioning of a 
democratic society, necessary to check against corruption, and needed 
to hold government officials accountable to the public. All members of 
the public are beneficiaries of the FOIA, and while this includes 
parties to a litigation, historically, a requester's rights are not 
affected by his or her litigation need for government records. See NLRB 
v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 n.23 (1978). We 
additionally note that the number of FOIA requests which the Department 
must process has increased exponentially since 1990, which is yet 
another reason why we have decided to only grant expedited processing 
in very limited circumstances. For these reasons, we disagree with the 
commenter's contention that CMS does not have a good reason to depart 
from its current expedited processing policy.
    A second commenter recommended that HHS provide for expedited 
processing of state survey documents such as investigator notes, 
witness statements, witness lists, and documents reviewed during the 
course of the investigation. The commenter believes that HHS should 
commit to responding to these types of requests so that nursing home 
residents can receive these documents before their claims are time 
barred by a statute of limitations. We must, unfortunately, decline to 
accept this recommendation. While specific requesters may have a strong 
personal need to receive responsive records as quickly as possible, the 
agency must consider the interests of all requesters waiting patiently 
in line and make sure that everyone is treated equally. As a result, we 
only grant expedited processing in truly exceptional circumstances. 
Moreover, the FOIA is fundamentally meant to inform the public about 
agency action and not to benefit private litigants. NLRB v. Sears 
Roebuck & Co., 421 U.S. 132, 143 n.10 (1975). For those reasons, we 
decline to accept this recommendation.
    One commenter recommended that a requester's history of making 
requests for expedited processing should be considered when determining 
whether to grant expedited processing. In the opinion of the commenter, 
organizations that always request expedited processing for all requests 
should receive greater scrutiny in their requests for expedited 
processing than organizations that do not request expedited processing 
when their requests are obviously not urgent. In response to this 
comment, we decline to accept the commenter's recommendation. Each 
request for expedited processing is evaluated on its own merits. We do 
not provide special treatment to some requesters over others based on 
their history of making requests.
    When granting expedited processing, one commenter thought that we 
should consider the fact that a requester has a

[[Page 74936]]

history of making requests for records that eventually became 
frequently requested records. In response to this comment, we decline 
to accept the commenter's recommendation. Each request for expedited 
processing is evaluated on its own merits. We do not provide special 
treatment to some requesters over others based on a history of 
requesting records that become frequently requested records.
    One commenter recommended granting expedited processing in 
situations where the requested records implicate an ongoing public 
health issue. We grant expedited processing in two cases: (1) Where 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, and (2) where there is an urgent need 
to inform the public about an actual or alleged Federal Government 
activity. We only grant expedited processing in limited circumstances 
because we must consider the interests of all requesters waiting 
patiently in line and make sure that everyone is treated equally. For 
this reason, we must decline to adopt this comment.
    Finally, one commenter suggested that records released in response 
to a request that receives expedited processing or a fee waiver should 
be made proactively available one year after it is released to the 
requester even if the information has not been requested three or more 
times. We have decided not to accept this comment. Even if a record has 
not been released and requested three or more times, we will make 
available additional records if we believe they are of interest to the 
public and are appropriate for public disclosure. However, not every 
record released in response to a request that receives expedited 
processing or a fee waiver may fall into that category.

How does HHS respond to my request? (Sec.  5.28)

    Several commenters recommended modifying the rule to incorporate 
changes made to the FOIA as a result of the FOIA Improvement Act. As a 
result of the FOIA Improvement Act, we have modified the language of 
Sec.  5.28(a) to indicate that we will provide requesters with a 
notification of their right to seek assistance from the appropriate 
FOIA Public Liaison in all disclosure determination letters, and we 
have modified Sec.  5.28(b) to indicate that we will provide requesters 
with a notification of their right to seek dispute resolution services 
from the appropriate FOIA Public Liaison and the Office of Government 
Information Services in all disclosure determination letters that 
include an adverse determination.

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

    One commenter wanted to know who at the various offices is 
available for helping to ensure that the FOIA is processed properly. 
The commenter can seek assistance from the FOIA Requester Service 
Center that is processing the request. Each FOIA Requester Service 
Center also has a FOIA Public Liaison who can assist in reducing 
delays, clarifying the scope of a request, increasing transparency, 
providing status updates, and assisting in dispute resolution. The 
contact information for each FOIA Requester Service Center and the name 
of each FOIA Public Liaison is available through the web link included 
in this section. In addition, requesters can seek assistance from the 
Office of Government Information Services (OGIS) including mediation 
services.
    Several commenters suggested modifying the rule to incorporate the 
requirements of the FOIA resulting from the FOIA Improvement Act. 
Section 3 of the FOIA Improvement Act requires each agency to include 
procedures for engaging in dispute resolution with the FOIA Public 
Liaison and the Office of Government Information Services (OGIS). These 
procedures are included in this section of the rule. In addition, 
throughout the rule, we have included provisions that provide for the 
assistance of the appropriate FOIA Public Liaison and the Office of 
Government Information Services (OGIS) or give notification of their 
services.

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

    One commenter stated that a section describing the exemptions to 
the FOIA was unnecessary, and at most should simply restate the 
exemptions set forth in 5 U.S.C. 552(b). The commenter further stated 
that the scope of the exemptions is determined by the courts and not 
agency regulations. After considering this comment and other comments 
concerning this section, we have removed language describing the scope 
of each exemption and simply restated the exemptions as set forth in 
the FOIA statute.
    One commenter suggested revising the opening paragraph of Sec.  
5.31 to reflect the presumption of openness codified in the FOIA 
Improvement Act. Another commenter suggested adding similar language to 
the end of the section. We have made the recommended change and have 
included a reference to the foreseeable harm standard in this section. 
We have chosen to place this reference in the opening paragraph of the 
section.
    One commenter noted that all FOIA exemptions are discretionary, not 
mandatory. Therefore, all language describing an Exemption should state 
that an Exemption ``authorizes'' the withholding of information instead 
of ``requires''. We have accepted this comment and made the recommended 
change. We note, however, that the ability to make a discretionary 
release will vary according to the exemption involved and whether the 
information is required to be protected by some other legal authority. 
Some of the FOIA's exemptions, such as Exemption 2 and Exemption 5, 
protect a type of information that is not generally subject to a 
disclosure prohibition. By contrast, the exemptions covering national 
security, commercial and financial information, personal privacy, and 
matters within the scope of nondisclosure statutes protect records that 
are also encompassed within other legal authorities that restrict their 
disclosure to the public. See Attorney General Holder's FOIA 
Guidelines, 74 FR 51879, (October 8, 2009) (describing exemptions where 
discretionary disclosure can most readily be made and those for which 
discretionary disclosure is not available). Thus, agencies are 
constrained in their ability to make discretionary disclosures of 
records covered by Exemptions 1, 3, 4, 6, and & certain subparts of 
Exemption 7.
    Several commenters expressed concern regarding the descriptions of 
the scope of Exemptions 4, 5, and 6. These comments have been rendered 
moot, however, since the language in this section now simply restates 
the Exemptions as they are set forth in the FOIA statute.
    One commenter provided feedback on Sec.  5.31(d)(4)(ii) concerning 
the amount of time we provide submitters to respond to a predisclosure 
notification. The provision states that submitters have ten working 
days to object to disclosure and that HHS FOIA Offices may extend this 
period as appropriate and necessary. The commenter thought that we 
should take into consideration the time limits within which agencies 
must respond to FOIA requests. Furthermore, the commenter recommended 
that the regulation state that the agency will expeditiously provide 
predisclosure notification and should make clear that the amount of 
time provided to a submitter to respond to a predisclosure notification 
should not exceed the remaining amount of time in which the

[[Page 74937]]

agency is required by law to process the request. After considering 
this comment, we have decided not to accept it. We attempt to process 
all FOIA requests as expeditiously as possible. However, it sometimes 
is not possible to know whether a predisclosure notification is 
necessary to process a request or where a predisclosure notification 
needs to be sent until a search for records has been conducted and a 
review of the records has begun. It is unclear how adding a requirement 
that we expeditiously provide predisclosure notification would speed up 
that process. We also do not think it is reasonable to restrict a 
submitter's opportunity to object to disclosure based on the amount of 
time in which we are required by law to process the request. All 
submitters should be given ten working days (or where appropriate and 
necessary, ten or more working days) to object to the disclosure of 
information they provided to the government regardless of how long it 
takes for HHS to conduct the search or determine that a predisclosure 
notification is required.
    One commenter provided input regarding Sec.  5.41(d)(4)(iii). More 
specifically, the commenter expressed concern with the rule's language 
regarding the requirements of a notice of intent to disclose. The 
language, as written, suggested that we would release information over 
the objection of a submitter within five days of the date of the notice 
of intent to disclose. The commenter suggested that this could 
potentially allow for a release of information less than five days 
after the notice of intent to release, which would be unreasonable. The 
commenter also noted that the timeframe for the release of records 
after a notice of intent to disclose was based on the date of the 
notice whereas with Sec.  5.41(d)(4)(ii), the date to provide 
objections to a predisclosure notification was based on the date of 
receipt of the notification. Moreover, as written, FOIA Offices were 
given the authority to extend the timeframe for responding to a 
predisclosure notification letter but not for releasing records after 
providing a notice of intent to release. In accordance with Executive 
Order 12600 and in response to this comment, we have modified the 
requirements regarding the notice of intent to disclose to require that 
the notice include a specified disclosure date and that the date be at 
least five working days after the date of the notice. This will provide 
a reasonable number of days before a release and it gives flexibility 
to FOIA Offices to provide more than five working days when necessary. 
In order to be consistent, we also have revised the predisclosure 
notification procedures to base the amount of time to object on the 
date of the notice rather than the date of receipt. This is 
administratively easier to track and, as communication has become more 
electronic, the date of the notice and the date of receipt are often 
the same. Finally, all provisions regarding confidential commercial 
information are now located in their own subpart, Subpart D.
    Multiple commenters suggested modifying the description of 
Exemption 5 to include the restriction on applying the deliberative 
process privilege to records that were created 25 years or more before 
the date on which the records were requested. This limitation to the 
deliberative process privilege was added by the FOIA Improvement Act 
and it is now reflected in this rule.

Records Not Subject to the Requirements of the FOIA--Law Enforcement 
Exclusions (Sec.  5.32)

    One commenter stated that they found it unusual and highly 
irregular for HHS to include a description of the law enforcement 
record exclusions. In response to this comment, we have removed the 
descriptions of the exclusions and have simply included a citation to 
the section of the FOIA statute that references exclusions.

General Information on Fees for All FOIA Requests (Formerly Sec.  5.41)

    One commenter recommended that requesters be given at least 20 
working days to make an advance payment (Sec.  5.41(b)) or respond to 
an agency communication in the course of negotiating fees (Sec.  
5.41(e)) and, if the agency takes more than twenty working days from 
the date of the request to initiate these actions with the requester, 
the requester should receive the same amount of time to respond to the 
agency. In response to this comment, we have increased the number of 
days to make an advance payment and respond to an agency communication 
from at least 10 working days to at least 20 working days. We believe 
that this provides requesters with a reasonable amount of time to 
respond to us before we assume that they are no longer interested in 
pursuing their request.

What Fee Policies Apply to HHS Records? (Formerly Sec.  5.42)

    One commenter suggested editing the provision on minimum fees to 
state that ``[w]e do not send an invoice to requesters if assessable 
processing fees are less than $25.'' We have accepted the commenter's 
suggestion and made the change.

What is the FOIA Fee Schedule for Obtaining Records? (Formerly Sec.  
5.43)

    Two commenters recommended removing language related to the fees we 
charge for the use of a computer to conduct a search in Sec.  
5.43(a)(2). One commenter thought that the language was archaic and 
should be removed. The second commenter considered the cost of a 
computer to be a sunk cost to the Department and stated that the 
computer would have been running anyway if it hadn't been used to 
conduct the search. We decline to accept the commenters' 
recommendations. When establishing the fee schedule, we follow the 
Uniform Freedom of Information Fee Schedule and Guidelines published by 
the Office of Management and Budget (OMB), which establishes uniform 
standards for fee matters. Conformity with the OMB Guidelines is 
required by the FOIA. See 5 U.S.C. 552(a)(4)(A)(i). The OMB Fee 
Guidelines state that with regard to computer searches for records 
``[a]gencies should charge at the actual direct cost of providing the 
service. This will include the cost of operating the [computer] for 
that portion of operating time that is directly attributable to 
searching for records responsive to a FOIA request and operator/
programmer salary apportionable to the search.'' In order to conform 
with the OMB Fee Guidelines, we have included the same provision in our 
rule.

How does HHS Calculate FOIA Fees for Different Categories of 
Requesters? (Formerly Sec.  5.44)

    The commenter thought that some of the language in Sec.  5.44(c) 
was potentially redundant and ambiguous. The commenter did not consider 
it necessary to state both that if you do not fall into the categories 
in paragraphs (a) and (b) of this section (a commercial requester or an 
educational or noncommercial scientific institution requester, or a 
member of the news media), you are an ``other requester''. The 
commenter believed that this language suggested a conjunctive 
relationship when none was intended to exist. The commenter suggested 
using ``i.e.'' instead of ``and are'' to clarify things. In response to 
this comment, we have edited Sec.  5.44(c) to make the language 
identifying an ``other requester'' clearer.
    Multiple commenters recommended amending this section in order to 
reference new provisions to the FOIA created by the FOIA Improvement 
Act that place further limitations on assessing search fees (or, for a 
requester

[[Page 74938]]

with preferred status, duplication fees) if response time is delayed. 
At the recommendation of the commenters and in accordance with the FOIA 
Improvement Act, the recommended change has been made to this section.

How may I request a fee waiver? (formerly Sec.  5.45)

    One commenter expressed concern with the description of the factors 
described in Sec.  5.45(b) used to determine whether a requester is 
eligible for a fee waiver or a reduction in fees. The commenter 
specifically pointed out an issue with Sec.  5.45(b)(5) which stated 
that, to be eligible for a fee waiver, a requester must explain how the 
requester ``intend[s] to disseminate the requested information to a 
broad spectrum of the public.'' The commenter noted that in Cause of 
Action v. FTC, the D.C. Circuit specifically held that ``proof of the 
ability to disseminate the released information to a broad cross-
section of the public is not required.'' 799 F.3d 1108, 1116 (D.C. Cir. 
2015). Rather, ``the relevant inquiry . . . is whether the requester 
will disseminate the disclosed records to a reasonably broad audience 
of persons interested in the subject.'' Id. In addition to noticing an 
issue with Sec.  5.45(b)(5), the commenter also thought Sec.  
5.45(b)(5) and Sec.  5.45(b)(4) were duplicative. Likewise, the 
commenter thought that Sec.  5.45(b)(3) should be deleted because it 
duplicated Sec. Sec.  5.45(b)(1), (2), (4) & (6). The commenter 
expressed concern that if these duplicative provisions remained in the 
rule, requesters would have to repeat the same information numerous 
times in order to be eligible for a fee waiver. In response to this 
comment, we have modified this section to include a streamlined list of 
the fee waiver factors based on Cause of Action v. FTC. We believe that 
this streamlined list satisfies the commenter's concerns of correctly 
stating the standard for being able to disseminate information and 
reducing redundancy.

How do I file an appeal? (formerly Sec.  5.52)

    As a result of an amendment to the FOIA by the FOIA Improvement 
Act, two commenters recommended increasing the number of days to appeal 
an adverse determination to no less than 90 days after the date of an 
adverse determination. We have accepted this comment and increased the 
number of days to appeal to 90 days after the date of an adverse 
determination. Note that the contents of this provision have moved to 
Sec.  5.61 (When may I appeal HHS's FOIA determination?).
    One commenter suggested that we use the postmark date rather than 
the date the appeal is received by the agency when determining whether 
an appeal has been submitted in a timely manner. The same commenter 
suggested that the appeal timeframe commence once the disclosure 
determination is received by the requester instead of the date of the 
adverse determination letter. After considering this comment, we have 
decided to partially accept it. The rule has been modified to indicate 
that we will base the timeliness of an appeal on the postmark date or, 
in the case of an electronic submission, the transmittal date. The rule 
has been further modified, however, to stipulate that if a postmark 
date is illegible, we will revert to using the date of receipt to 
determine the timeliness of the appeal submission. We also specify that 
an electronic submission transmitted after normal business hours will 
be considered transmitted on the next day for the purposes of 
determining the timeliness of an appeal submission. Finally, we reject 
the commenter's suggestion that the appeal timeframe commence once 
notice of the adverse determination is received by the requester. The 
FOIA statute itself bases the minimum timeframe that agencies must 
provide for a requester to appeal a request on a specific number of 
days ``after the date of such adverse determination'', not on the date 
such determination is received by the requester. Moreover, we believe 
that a 90 day appeal timeframe, as currently structured, provides 
requesters with a reasonable amount of time to submit a timely request. 
Note that the provision discussed by this comment has moved to Sec.  
5.61 (When may I appeal HHS's FOIA determination?).
    One commenter observed that Sec.  5.52(b) stated that an appeal 
could be submitted electronically; however, in the opinion of the 
commenter, the rule failed to identify a means of submitting 
administrative appeals electronically. In response to this comment, we 
have clarified that instructions on how to submit a FOIA appeal 
electronically can be found by using the web links provided in the 
section.

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

    One commenter expressed concern with the language in paragraph (a) 
of Sec.  5.54, which states that a requester must submit an 
administrative appeal in order to seek judicial review. In expressing 
this concern, the commenter suggested that this language was dubious 
and referenced examples cited in the Department of Justice Guide to the 
Freedom of Information Act where multiple courts had held that 
``exhaustion of administrative remedies is not required prior to 
seeking court review of an agency's denial of requested expedited 
access.'' U.S. DEP'T OF JUSTICE, Litigation Considerations 44 & n. 144, 
GUIDE TO THE FREEDOM OF INFORMATION ACT (last updated Nov. 26, 2013), 
available at https://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/litigation-considerations.pdf#p29. In response to this 
comment, we have amended the language to state that ``[b]efore seeking 
review by a court of an adverse determination, you generally must first 
submit a timely administrative appeal.'' The modified language informs 
requesters of the need to generally submit an administrative appeal 
prior to seeking judicial review without suggesting that this is 
required in all cases.

Miscellaneous

    One commenter suggested that we provide our understanding of what 
the term ``due diligence'' means. Based on the context of the comment, 
it appears that the commenter was referring to the use of the term in 
the FOIA statute at 5 U.S.C. 552(a)(6)(C)(i), which states that ``[i]f 
the Government can show exceptional circumstances exist and that the 
agency is exercising due diligence in responding to the request, the 
court may retain jurisdiction and allow the agency additional time to 
complete its review of the records.'' We believe that the concept of 
exceptional circumstances is adequately explained in the FOIA statute 
and it is unnecessary to include a provision about that subject in this 
rule. With regard to the term ``due diligence'', we believe that the 
term can best be understood by the plain meaning in the statute, 
legislative intent, and any case law interpreting that term. We, 
therefore, decline to provide any further interpretation of this term.
    One commenter noted that in certain cases we spelled out numbers 
and in other cases we used figures. Compare, e.g., Sec.  
5.31(d)(4)(iii)(``5 working days''), and Sec.  5.23(b)(``10 working 
days''), with Sec.  5.31(d)(5)(iv)(``five working days''), and Sec.  
5.25(f)(``ten working days''). In response to this comment, we have 
replaced the referenced spelled out numbers with figures.
    Finally, in response to public comments and feedback from within 
the Department, we have made the following changes: moved and clarified 
the provision on oral requests from Sec.  5.2(a) to Sec.  5.22(e); 
clarified the definition of non-commercial scientific

[[Page 74939]]

institution (Sec.  5.3); clarified the definition of fee waiver (Sec.  
5.3); removed references to the Program Support Center (PSC) 
(Sec. Sec.  5.3, 5.62(b)(2) (formerly Sec.  5.52(b)(2))) (the PSC FOIA 
Office has been dissolved and its responsibilities have transferred to 
the Office of the Secretary (OS) FOIA Office); renamed ``reading room'' 
``FOIA Library'' (Sec.  5.3, Sec.  5.22(i)); clarified the definition 
of ``record'' (Sec.  5.3); clarified the definition of ``submitter'' 
(Sec.  5.3); clarified that an individual seeking records under the 
Privacy Act has access rights under the FOIA (Sec.  5.5); clarified the 
information needed to make a first-party request (Sec.  5.22(f)) and a 
third-party request (Sec.  5.22(g)); added additional information 
describing when a requester should provide a HIPAA Authorization Form 
(Sec.  5.22(h) (formerly Sec.  5.22(c)); merged the contents of Sec.  
5.24 (Does HHS accept electronic FOIA requests?) with Sec.  5.23 (Where 
do I send my FOIA request?); removed unnecessary language from Sec.  
5.25(a); revised language in Sec. Sec.  5.24(b) and (c) (formerly 
Sec. Sec.  5.25 (b) and (c)) to distinguish the procedures used to 
assist a requester in perfecting their request from those used to 
clarify a reasonably described request through tolling; removed 
unnecessary language from Sec. Sec.  5.27(a) and 5.28(a); clarified the 
language in Sec.  5.28(d); moved confidential commercial information 
procedures to its own subpart (Sec. Sec.  5.41-5.42); removed former 
Sec.  5.31(d)(4)(iv) because it was redundant to Sec.  5.31(d)(4)(v) 
(now located at Sec.  5.42(a)(4)); removed unnecessary language from 
former Sec.  5.31(d)(4)(iii) (now located at Sec.  5.42(a)(3)); merged 
former Sec.  5.42 (What fee policies apply to HHS records?) with former 
Sec.  5.41 (General information on fees for all FOIA requests.) (now 
located at Sec.  5.51); clarified the notice provisions of Sec.  
5.51(a) (formerly Sec.  5.41(a)) to conform with the OMB Fee 
Guidelines; removed Sec.  5.51(i) (formerly Sec.  5.42(c)) as a result 
of the clarification of Sec.  5.51(a) (formerly Sec.  5.41(a)); 
replaced a reference to a Web site where FOIA fee rates would be posted 
with a description of the calculation used to determine hourly rates 
for manual searching, computer operator/programmer time, and time spent 
reviewing records (Sec.  5.52 What is the FOIA fee schedule for 
obtaining records?) (formerly Sec.  5.43); and clarified Sec.  
5.52(c)(2) (formerly Sec.  5.43(c)(2)).

Regulatory Analysis

Executive Order 12866

    The 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 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 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 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 rule 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.

Paperwork Reduction Act

    The 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.

0
In consideration of the foregoing, HHS revises 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 How does HHS process my FOIA request?
5.25 How does HHS handle requests that involve more than one OpDiv, 
StaffDiv, or Federal agency?
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--Confidential Commercial Information
5.41 How does a submitter identify records containing confidential 
commercial information?
5.42 How does HHS process FOIA requests for confidential commercial 
information?
Subpart E--Fees
5.51 General information on fees for all FOIA requests.
5.52 What is the FOIA fee schedule for obtaining records?
5.53 How does HHS calculate FOIA fees for different categories of 
requesters?
5.54 How may I request a fee waiver?
Subpart F--Appeals
5.61 When may I appeal HHS's FOIA determination?
5.62 How do I file an appeal?
5.63 How does HHS process appeals?
5.64 What avenues are available to me if I disagree with HHS's 
appeal decision?
Subpart G--Records Retention
5.71 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 
should be read in conjunction with the text of the FOIA and the Uniform 
Freedom of Information Fee Schedule and Guidelines published by the 
Office of Management and Budget. 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

[[Page 74940]]

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 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. The 
procedures for requesting research data made available under the 
provisions of 45 CFR 75.322(e) are referenced in Sec.  5.23(a).


Sec.  5.2  Presumption of openness and proactive disclosures.

    (a) We will administer the FOIA with a presumption of openness. In 
accordance with 5 U.S.C. 552(a)(8) we will disclose records or 
information exempt from disclosure under the FOIA whenever disclosure 
would not foreseeably harm an interest protected by a FOIA exemption 
and disclosure is not prohibited by law. We also will consider whether 
partial disclosure of information is possible whenever we determine 
that a full disclosure of a requested record is not possible. This 
includes taking reasonable steps to segregate and release nonexempt 
information.
    (b) Records that the FOIA requires agencies to make available for 
public inspection in an electronic format may be accessed through each 
OpDiv's and Staff Div's Web site. Each OpDiv and StaffDiv is 
responsible for determining which of its records must be made publicly 
available (including frequently requested records), for identifying 
additional records of interest to the public that are appropriate for 
public disclosure, and for posting and indexing such records. Each 
OpDiv and StaffDiv must ensure that its Web site of posted records and 
indices is reviewed and updated on an ongoing basis. Each OpDiv and 
StaffDiv has a FOIA Requester Service Center or FOIA Public Liaison who 
can assist individuals in locating records. A list of agency FOIA 
Public Liaisons is available at http://www.foia.gov/report-makerequest.html.


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 on behalf of 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.  5.52.
    Educational institution means any school that operates a program of 
scholarly research. A requester in this fee category must show that the 
request is made in connection with his or her role at the educational 
institution. Agencies may seek assurance from the requester that the 
request is in furtherance of scholarly research.
    Example 1. A request from a professor of geology at a university 
for records relating to soil erosion, written on letterhead of the 
Department of Geology, would be presumed to be from an educational 
institution.
    Example 2. A request from the same professor of geology seeking 
drug information from the Food and Drug Administration in furtherance 
of a murder mystery he is writing would not be presumed to be an 
institutional request, regardless of whether it was written on 
institutional stationery.
    Example 3. A student who makes a request in furtherance of their 
coursework or other school-sponsored activities and provides a copy of 
a course syllabus or other reasonable documentation to indicate the 
research purpose for the request, would qualify as part of this fee 
category.
    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.  5.53.

[[Page 74941]]

    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 because it is likely to contribute significantly to 
public understanding of the operations or activities of the government 
and is not primarily in the commercial interest of the requester.
    First-party request means a request by an individual for records 
pertaining to that individual, or an authorized representative acting 
on such 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 Requester 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 that reasonably describes the 
records sought.
    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 https://www.justice.gov/oip/freedom-information-act-5-usc-552.
    FOIA library 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). We make FOIA library records available to the public 
electronically through our Web pages (http://www.hhs.gov/foia/reading/index.html) and at certain physical locations. A list of the physical 
locations is available at http://www.hhs.gov/foia/contacts/index.html. 
Other records may also be made available at our discretion through our 
Web pages (http://www.hhs.gov).
    Freedom of Information Act (FOIA) 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 Act (FOIA) 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 offices. Apart 
from records subject to proactive disclosure pursuant to subsection 
(a)(2) of the FOIA, only FOIA 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 Requester Service 
Center has a designated official with this authority; the contact 
information for each FOIA Requester Service Center is available at 
http://www.hhs.gov/foia/contacts/index.html.
    (1) The HHS Freedom of Information Act (FOIA) 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 Act (FOIA) 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) [Reserved]
    Frequently requested records means records, regardless of form or 
format, that have been released to any person under the FOIA and that 
have been requested 3 or more times or 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 offices within 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, the 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 
not operated to further a commercial, trade, or profit interest and 
that is operated solely for the purpose of conducting scientific 
research the results of which are not intended to promote any 
particular product or industry. A requester in this category must show 
that the request is authorized by and is made under the auspices of a 
qualifying institution and that the records are sought to further 
scientific research and are not for a commercial use.
    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 for the records it maintains.
    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. 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 Division (OpDiv) 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).

    Operating Division and Staff Division Freedom of Information Act 
(FOIA) Officers means the officials who are responsible for overseeing 
the daily operations of their FOIA programs in their respective 
Operating Divisions or Staff Divisions, with the full authority as 
described in the definition of Freedom of Information Act (FOIA) 
Officer. These individuals serve as the principal resource and 
authority for FOIA operations and implementation within their 
respective Operating Divisions or Staff Divisions.
    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.
    Record means any information that would be an agency record when

[[Page 74942]]

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.
    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.
    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 Division (StaffDiv) 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 for 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, including a corporation, 
State, or foreign government, but not including another Federal 
Government entity, that provides commercial or financial information, 
either directly or indirectly to the Federal Government.
    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.  5.24.


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 and the FOIA. 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 Requester 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 records. 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 records about you. If any part of your request 
includes records about yourself that are maintained within a system of 
records as defined by the Privacy Act at 5 U.S.C. 552a(a)(5), 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. We will process the request under 
the Privacy Act and, if it is not fully granted under the Privacy Act, 
we will process it under the FOIA. You may obtain, under the FOIA, 
information that is exempt from access under the Privacy Act, if the 
information is not excluded or exempt under the FOIA. If you request 
records about yourself that are not maintained within a system of 
records, we will process your request under the FOIA only.
    (b) Requesting records about another individual. If you request 
records about another individual, we will process your request under 
the FOIA. You may receive greater access by following the procedures 
described in Sec.  5.22(g).

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. This includes state and 
local governments.


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

    In your FOIA request:
    (a) Provide a written description of 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) State your willingness to pay all fees, or the maximum amount 
of fees you are willing to pay, and/or include a request for a fee 
waiver/reduction.
    (d) Mark both your letter and envelope, or the subject line of your 
email, with the words ``FOIA Request.''
    (e) If you are unable to submit a written request to us due to 
circumstances such as disability or literacy, you may make a request 
orally to a FOIA Officer. FOIA Officers will put in writing an oral 
request made directly to them.
    (f) If you are making a first-party request, you must comply with 
the verification of identity procedures set forth in 45 CFR part 5b.

[[Page 74943]]

    (g) Where your request for records pertains to another individual, 
you may receive greater access by submitting either a notarized 
authorization signed by that individual or a declaration made in 
compliance with the requirements set forth in 28 U.S.C. 1746 by that 
individual authorizing disclosure of the records to the requester, or 
by submitting proof that the individual is deceased (e.g., a copy of a 
death certificate or an obituary). At our discretion, we may require 
you to supply additional information if necessary to verify that a 
particular individual has consented to disclosure of records about 
them.
    (h) If you are requesting the medical records of an individual 
other than yourself from a government program that pays or provides for 
health care (e.g. Medicare, Indian Health Service) 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: ttps:/
/www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10106.pdf.
    (i) Before filing your request, you may find it helpful to consult 
the HHS FOIA Requester 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 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 FOIA libraries 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 Requester Service Centers (FOIA offices) that 
process FOIA requests. You should send your FOIA request to the 
appropriate FOIA Requester 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. You also may submit your 
request electronically by emailing it to the appropriate FOIA Requester 
Service Center or by submitting it to the Department's web portal 
located at https://requests.publiclink.hhs.gov/palMain.aspx.
    (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 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 
Requester Service Center with responsibility for the 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 
Requester Service Centers.
    (c) If you have questions concerning the processing of your FOIA 
request, you may contact the FOIA Requester 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 Requester Service Centers and Public Liaisons at http://www.hhs.gov/foia/contacts/index.html.


Sec.  5.24  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. In addition, the 
acknowledgement letter or email or a subsequent communication may also 
seek additional information to clarify your request.
    (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 either has been received by the responsible FOIA 
office, or, in any event, not later than 10 working days after the 
request has been received by any HHS FOIA office;
    (ii) The requested records are reasonably described; and
    (iii) The request contains sufficient information to enable the 
FOIA office to contact you and transmit records to you.
    (2) We provide at least 20 working days for you to respond to a 
request to perfect your request, after notification. Requests must 
reasonably describe the records sought and contain sufficient 
information to enable the FOIA office to contact you and transmit 
records to you. If we determine that a request does not meet these 
requirements, we will attempt to contact you if possible. 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. 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 20 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 may 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. We 
will place your request in the simple or complex processing queue based 
on the estimated amount of work or time needed to process the request. 
Among the factors we may consider are the number of records requested, 
the number of pages involved in processing the request, and the need 
for consultations or referrals. We will advise requesters of potential 
complicating factors in our

[[Page 74944]]

acknowledgement letter or email, or in subsequent communications 
regarding your request and, when appropriate, we will offer requesters 
an opportunity to narrow or modify their request so that it can be 
placed in the simple processing track.
    (f) Unusual Circumstances. Whenever we cannot meet the statutory 
time limit for processing a request because of ``unusual 
circumstances,'' as defined in the FOIA, and we extend the time limit 
on that basis, we will notify you, before expiration of the 20-day 
period to respond and in writing of the unusual circumstances involved 
and of the date by which we estimate processing of the request will be 
completed. Where the extension exceeds 10 working days, we will provide 
you, as described by the FOIA, with an opportunity to modify the 
request or arrange an alternative time period for processing the 
original or modified request. We will make available a designated FOIA 
contact in the appropriate FOIA Requester Service Center or the 
appropriate FOIA Public Liaison for this purpose. In addition, we will 
inform you of the right to seek dispute resolution services from the 
Office of Government Information Services (OGIS).
    (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.


Sec.  5.25  How does HHS handle requests that involve more than one 
OpDiv, StaffDiv, or Federal agency?

    (a) Re-routing of misdirected requests. When a FOIA Requester 
Service Center determines that a request was misdirected within HHS, 
the receiving FOIA Requester Service Center must route the request to 
the FOIA Requester Service Center of the proper OpDiv or StaffDiv 
within HHS.
    (b) Consultation, referral, and coordination. When reviewing 
records located by an OpDiv or StaffDiv in response to a request, the 
OpDiv or StaffDiv will determine whether another agency of the Federal 
Government is better able to determine whether the record is exempt 
from disclosure under the FOIA. As to any such record, the OpDiv or 
StaffDiv must proceed in one of the following ways:
    (1) Consultation. When records originated with an OpDiv or StaffDiv 
processing the request, but contain within them information of interest 
to another OpDiv, StaffDiv, agency or other Federal Government office, 
the OpDiv or StaffDiv processing the request should typically consult 
with that other entity prior to making a release determination.
    (2) Referral. (i) When the OpDiv or StaffDiv processing the request 
believes that a different OpDiv, StaffDiv, or agency is best able to 
determine whether to disclose the record, the OpDiv or StaffDiv 
typically should refer the responsibility for responding to the request 
regarding that record to that other entity. Ordinarily, the entity that 
originated the record is presumed to be the best entity to make the 
disclosure determination. However, if the OpDiv or StaffDiv processing 
the request and the originating entity jointly agree that the OpDiv or 
StaffDiv processing the request is in the best position to respond 
regarding the record, then the record may be handled as a consultation.
    (ii) Whenever an OpDiv or StaffDiv refers any part of the 
responsibility for responding to a request to another OpDiv, StaffDiv, 
or federal agency, it must document the referral, maintain a copy of 
the record that it refers, and notify the requester of the referral; 
informing the requester of the name(s) of the entity to which the 
record was referred, including that entity's FOIA contact information.
    (3) Coordination. The standard referral procedure is not 
appropriate where disclosure of the identity of the OpDiv, StaffDiv, or 
federal agency to which the referral would be made could harm an 
interest protected by an applicable exemption, such as the exemptions 
that protect personal privacy or national security interests. In such 
instances, in order to avoid harm to an interest protected by an 
applicable exemption, the OpDiv or StaffDiv that received the request 
should coordinate with the originating entity to seek its views on the 
disclosability of the record. The release determination for the record 
that is the subject of the coordination should then be conveyed to the 
requester by the OpDiv or StaffDiv that originally received the 
request.
    (c) Classified information. On receipt of any request involving 
classified information, the OpDiv or StaffDiv must determine whether 
the information is currently and properly classified in accordance with 
applicable classification rules. Whenever a request involves a record 
containing information that has been classified or may be appropriate 
for classification by another agency under any applicable executive 
order concerning the classification of records, the OpDiv or StaffDiv 
must refer the responsibility for responding to the request regarding 
that information to the agency that classified the information, or 
which should consider the information for classification. Whenever an 
OpDiv's or StaffDiv's record contains information that has been 
derivatively classified (for example, when it contains information 
classified by another agency), the OpDiv or StaffDiv must refer the 
responsibility for responding to that portion of the request to the 
agency that classified the underlying information.
    (d) Timing of responses to consultations and referrals. All 
consultations and referrals received by the Department will be handled 
according to the date that the FOIA request initially was received by 
the first OpDiv, StaffDiv, or federal agency.
    (e) Agreements regarding consultations and referrals. OpDivs or 
StaffDivs may establish agreements with other OpDivs, StaffDivs, or 
federal agencies to eliminate the need for consultations or referrals 
with respect to particular types of records.


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

    (a) When we provide an estimated completion date, in accordance 
with Sec.  5.24(f) and upon request, 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 we provide an estimated completion date, in accordance 
with Sec.  5.24(f) and upon request, 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) 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 at http://www.hhs.gov/foia/contacts/index.html. You may request expedited processing when you first request 
records or at any time during our processing of your request or appeal.
    (b) We process requests on an expedited basis whenever we determine

[[Page 74945]]

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).
    (c) 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 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.
    (d) If we must refer records to another agency, we will inform you 
and suggest that you seek expedited review from that agency.


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, 
any fees you must pay for processing of the request, and your right to 
seek assistance from the appropriate FOIA Public Liaison.
    (b) If we deny any part of your request, our response will explain 
the reasons for the denial, which FOIA exemptions apply to the withheld 
records, your right to appeal that determination, and your right to 
seek dispute resolution services from the appropriate FOIA Public 
Liaison or the Office of Government Information Services (OGIS). 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.
    (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 list the exemptions to disclosure that may apply to 
agency records.
    (d) We also may deny your request for other reasons, including 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 Requester 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 
Requester 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 Requester Service Centers allow 
you to check the status of your request online. You can find a list of 
our FOIA Requester 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 through mediation. Mediation is a voluntary 
process. If we participate in the dispute resolution services provided 
by OGIS, we will actively engage as a partner to the process in an 
attempt to resolve the dispute and will follow the principles of 
confidentiality in accordance with the Administrative Dispute 
Resolution Act, 5 U.S.C. 571-8. 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 and disclosure would 
either foreseeably harm an interest protected by a FOIA exemption or 
disclosure is prohibited by law. We review all records and weigh and 
assess all legal and policy requirements prior to making a final 
disclosure determination. A description of the nine FOIA exemptions is 
provided in paragraphs (a) through (i) of this section.
    (a) Exemption 1. Exemption 1 protects from disclosure information 
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.
    (b) Exemption 2. Exemption 2 authorizes our agency to withhold 
records that are related solely to the internal personnel rules and 
practices of an agency.
    (c) Exemption 3. Exemption 3 authorizes 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 authorizes our agency to withhold 
trade secrets and commercial or financial information obtained from a 
person and privileged or confidential.
    (e) Exemption 5. Exemption 5 authorizes our agency to withhold 
inter-agency or intra agency memorandums or letters that would not be 
available by law to a party other than an agency in litigation with the 
agency, provided that the deliberative process privilege shall not 
apply to records created 25 years or more before the date on which the 
records were requested.

[[Page 74946]]

    (f) Exemption 6. Exemption 6 authorizes our agency to protect 
information in personnel and medical files and similar files when the 
disclosure of such information would constitute a clearly unwarranted 
invasion of personal privacy.
    (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):
    (1) Could reasonably be expected to interfere with enforcement 
proceedings;
    (2) Would deprive a person of a right to a fair trial or an 
impartial adjudication;
    (3) Could reasonably be expected to constitute an unwarranted 
invasion of personal privacy;
    (4) 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;
    (5) 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
    (6) Could reasonably be expected to endanger the life or physical 
safety of any individual.
    (h) Exemption 8. Exemption 8 authorizes our agency to withhold 
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 authorizes our agency to withhold 
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 narrow categories 
of law enforcement and national security records. The provisions 
protecting those records are known as ``exclusions'' and are described 
in 5 U.S.C. 552(c). 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.
    (a) 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.
    (b) 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--Confidential Commercial Information


Sec.  5.41  How does a submitter identify records containing 
confidential commercial information?

    A person who submits records to the government may designate part 
or all of the information in such records that they may consider to be 
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 10 years after the 
records were submitted to the government.


Sec.  5.42  How does HHS process FOIA requests for confidential 
commercial information?

    (a) Predisclosure notification. The procedures in this section 
apply to records on which the submitter has designated information as 
provided in Sec.  5.41. 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 (b) of this section.
    (1) 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.
    (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. FOIA Offices in HHS and its organizational 
components may extend this period as appropriate and necessary.
    (3) We review and consider all objections to release that we 
receive within the time limit. If a submitter fails to respond within 
the time period specified in the notice, we will consider the submitter 
to have no objection to disclosure of the information. 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 provide the submitter with a 
specific date that we intend to disclose the records, which must be at 
least 5 working days after the date of the notice. We do not consider 
any information we receive after the date of a disclosure decision.
    (4) If the requester files a lawsuit under the FOIA for access to 
records submitted to HHS, we promptly notify the submitter.
    (5) We will notify the requester in these circumstances:
    (i) When we notify a submitter that we 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;
    (ii) When the agency notifies a submitter of a final disclosure 
decision under the FOIA,
    and;
    (iii) When a submitter files a lawsuit to prevent the disclosure of 
the information.
    (b) Exceptions to predisclosure notification. The notice 
requirements in paragraph
    (a) of this section do not apply in the following situations:
    (1) We determine that we should withhold the information under a 
FOIA exemption;
    (2) The information has been lawfully published or made available 
to the public
    (3) 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
    (4) 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, at least 5 working days prior to the

[[Page 74947]]

specified disclosure date. We will notify the submitter as referenced 
in Sec.  5.42(a)(3).

Subpart E--Fees


Sec.  5.51  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. 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 
$25.00 or your specified 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 $250.00, we 
also may require advance payment or a deposit before we begin 
processing your request. If you fail to make an advance payment within 
20 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.
    (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 20 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.
    (g) 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.
    (h) We do not send an invoice to requesters if assessable 
processing fees are less than $25.00.


Sec.  5.52  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. The fees we charge for search and review are three-tiered, and 
the hourly charge is determined by the classification and grade level 
of the employee performing the search or review. When the search or 
review is performed by employees at grade GS-1 through GS-8 (or 
equivalent), an hourly rate will be charged 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 will be charged 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 will be charged 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 listed 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% of 
that rate to cover benefits, and rounding to the nearest whole dollar.
    (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 is $0.10 per page.
    (2) Reproduction of electronic records. We will attempt to provide 
records in the format you sought, if the records are reasonably and 
readily reproducible in the requested format. 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.
    (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.
    (f) Other statutes specifically providing for fees. The fee 
schedule of this section does not apply to fees charged under any 
statute that specifically requires an OpDiv or StaffDiv to set and 
collect fees for particular types of records. In instances where 
records responsive to a request are subject to a statutorily-based fee 
schedule program, the OpDiv or StaffDiv must inform the requester of 
the contact information for that program.


Sec.  5.53  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

[[Page 74948]]

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 (i.e. you 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)(1) If we fail to comply with the FOIA's time limits in which to 
respond to a request, we may not charge search fees, or, in the 
instances of the requester categories referenced in paragraph (b) of 
this section, may not charge duplication fees, except as described in 
(d)(2)-(4).
    (2) If we have determined that unusual circumstances as defined by 
the FOIA apply and we provided timely written notice to the requester 
in accordance with the FOIA, a failure to comply with the time limit 
shall be excused for an additional 10 days.
    (3) If we have determined that unusual circumstances, as defined by 
the FOIA, apply and more than 5,000 pages are necessary to respond to 
the request, we may charge search fees, or, in the instances of 
requests from requesters described in paragraph (b) of this section, 
may charge duplication fees if the following steps are taken: we must 
have provided timely written notice to the requester in accordance with 
the FOIA and must have discussed with the requester via written mail, 
email, or telephone (or made not less than three good-faith attempts to 
do so) how the requester could effectively limit the scope of the 
request in accordance with 5. U.S.C. 552(a)(6)(B)(ii). If this 
exception is satisfied, we may charge all applicable fees incurred in 
the processing of the request.
    (4) If a court has determined that exceptional circumstances exist, 
as defined by the FOIA, a failure to comply with the time limits shall 
be excused for the length of time provided by the court order.


Sec.  5.54  How may I request a fee waiver?

    (a) Requesters may seek a waiver of fees by submitting a written 
application demonstrating how disclosure of the requested information 
is in the public interest because it is likely to contribute 
significantly to public understanding of the operations or activities 
of the government and is not primarily in the commercial interest of 
the requester.
    (b) We must furnish records responsive to a request without charge 
or at a reduced rate when we determine, based on all available 
information, that the following three factors are satisfied:
    (1) Disclosure of the requested information would shed light on the 
operations or activities of the government. The subject of the request 
must concern identifiable operations or activities of the Federal 
Government with a connection that is direct and clear, not remote or 
attenuated.
    (2) Disclosure of the requested information would be likely to 
contribute significantly to public understanding of those operations or 
activities. This factor is satisfied when the following criteria are 
met:
    (i) Disclosure of the requested records must be meaningfully 
informative about government operations or activities. The disclosure 
of information that already is in the public domain, in either the same 
or a substantially identical form, would not be meaningfully 
informative if nothing new would be added to the public's 
understanding.
    (ii) The disclosure must contribute to the understanding of a 
reasonably broad audience of persons interested in the subject, as 
opposed to the individual understanding of the requester. A requester's 
expertise in the subject area as well as the requester's ability and 
intention to effectively convey information to the public must be 
considered. We will presume that a representative of the news media 
will satisfy this consideration.
    (3) The disclosure must not be primarily in the commercial interest 
of the requester. To determine whether disclosure of the requested 
information is primarily in the commercial interest of the requester, 
we will consider the following criteria:
    (i) We will identify whether the requester has any commercial 
interest that would be furthered by the requested disclosure. A 
commercial interest includes any commercial, trade, or profit interest. 
Requesters will be given an opportunity to provide explanatory 
information regarding this consideration.
    (ii) If there is an identified commercial interest, we will 
determine whether that is the primary interest furthered by the 
request. A waiver or reduction of fees is justified when the 
requirements of paragraphs (b)(1) and (2) of this section are satisfied 
and any commercial interest is not the primary interest furthered by 
the request. We ordinarily will presume that when a news media 
requester has satisfied factors (b)(1) and (2) of this section, the 
request is not primarily in the commercial interest of the requester. 
Disclosure to data brokers or others who merely compile and market 
government information for direct economic return will not be presumed 
to primarily serve the public interest.
    (c) 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.

Subpart F--Appeals


Sec.  5.61  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 in writing, and 
to be considered timely it must be postmarked, or in the case of 
electronic submissions, transmitted within 90 calendar days from the 
date of such determination. Any electronic transmission made after 
normal business hours will be considered to have been transmitted on 
the next calendar day. If a postmark is not legible, the timeliness of 
a submission will be based on the date that we receive the appeal. 
Adverse determinations include:
    (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 a request does not reasonably describe the 
records sought;
    (d) Determination that the record you sought was not subject to the 
FOIA;
    (e) Denial of a request for expedited processing;
    (f) Denial of a fee waiver request; or
    (g) Fee category determination.


Sec.  5.62  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.
    (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 Requester Service 
Center that processed your request to obtain that information.
    (2) The addresses to mail FOIA appeals for CMS and OS are, 
respectively: Centers for Medicare & Medicaid Services, Attn: Principal 
Deputy Administrator, Room C5-16- 03, 7500 Security Boulevard, 
Baltimore, MD 21244; and 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.

[[Page 74949]]

Additionally, information, including how to submit a FOIA appeal 
electronically, can be found at the following online locations for CMS 
and OS: https://www.cms.gov/Regulations-and-Guidance/Legislation/FOIA/filehow.html and https://requests.publiclink.hhs.gov/palMain.aspx.
    (3) When submitting an appeal, you should mark both your letter and 
envelope with the words ``FOIA Appeal'' or include the words ``FOIA 
Appeal'' in the subject line of your email. You should also include 
your FOIA request tracking number, a copy of your initial request, and 
a copy of 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.  5.63  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.  5.64  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). Before seeking review by a court of an adverse 
determination, you generally must first submit a timely administrative 
appeal.
    (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 G--Records Retention


Sec.  5.71  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.

    Note:  This document was received for publication by the Office 
of the Federal Register on October 19, 2016.
[FR Doc. 2016-25684 Filed 10-27-16; 8:45 am]
 BILLING CODE 4150-25-P