Privacy Act, Exempt Record System, 51910-51912 [2012-20889]
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Rules and Regulations
positions of trust with potential futures
customers.
[FR Doc. 2012–20962 Filed 8–27–12; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 21
[Docket No. FDA–2011–N–0252]
Office of the Secretary
45 CFR Part 5b
Privacy Act, Exempt Record System
Office of the Secretary, Food
and Drug Administration, HHS.
ACTION: Direct final rule.
AGENCY:
The Food and Drug
Administration (FDA) of the Department
of Health and Human Services (HHS)
will be implementing a new system of
records, 09–10–0020, ‘‘FDA Records
Related to Research Misconduct
Proceedings, HHS/FDA/OC.’’ HHS/FDA
is exempting this system of records from
certain requirements of the Privacy Act
to protect the integrity of FDA’s
scientific misconduct inquiries and
investigations and to protect the identity
of confidential sources in such
investigations. HHS/FDA is issuing a
direct final rule for this action because
the Agency expects that there will be no
significant adverse comment on this
rule.
SUMMARY:
This rule is effective January 10,
2013. Submit either electronic or
written comments by November 13,
2012. If HHS/FDA receives no
significant adverse comments within the
specified comment period, the Agency
will publish a document confirming the
effective date of the final rule in the
Federal Register within 30 days after
the comment period on this direct final
rule ends. If timely significant adverse
comments are received, the Agency will
publish a document in the Federal
Register withdrawing this direct final
rule before its effective date.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2011–N–
0252, by any of the following methods:
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DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (For
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
docket number for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Frederick Sadler, Division of Freedom
of Information, Office of Public
Information and Library Services, Food
and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857,
301–796–8975,
Frederick.Sadler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is implementing a new system of
records called the ‘‘FDA Records
Related to Research Misconduct
Proceedings.’’ The purpose of this
system of records is to implement FDA’s
responsibilities for addressing research
integrity and misconduct, in accordance
with the Public Health Service (PHS)
Policies on Research Misconduct (42
CFR part 93), for research performed by
persons who are FDA employees, agents
of the Agency, or who are affiliated with
the Agency by contract or agreement.
The term ‘‘research misconduct’’ is
defined at 42 CFR 93.103 to mean
‘‘fabrication, falsification, or plagiarism
in proposing, performing, or reviewing
research, or in reporting research
results.’’ The general policy of the PHS
Policies on Research Misconduct is that
‘‘Research misconduct involving PHS
support is contrary to the interests of the
PHS and the Federal government and to
the health and safety of the public, to
the integrity of research, and to the
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conservation of public funds.’’ (42 CFR
93.100(a)). The PHS Policies on
Research Misconduct provide for a
number of HHS administrative actions
that can be taken in response to a
research misconduct proceeding, such
as the suspension of a contract,
debarment, or an adverse personnel
action against a Federal employee (42
CFR 93.407). In addition, under 42 CFR
93.401, FDA shall at any time during a
research misconduct proceeding notify
HHS’ Office of Research Integrity (ORI)
immediately to ensure that FDA’s Office
of Criminal Investigations, HHS Office
of Inspector General, the Department of
Justice, or other appropriate law
enforcement agencies, are notified if
there is a reasonable indication of
possible violations of civil or criminal
law.
FDA’s new system of records will be
modeled after the system of records
maintained by ORI, entitled ‘‘HHS
Records Related to Research Misconduct
Proceedings, HHS/OPHS/ORI’’ System
No. 09–37–0021 (59 FR 36717, July 19,
1994; revised most recently at 75 FR
44847, August 31, 2009).
FDA’s scientific misconduct inquiry
and investigation records are located in
the Office of the Chief Scientist in
FDA’s Office of the Commissioner. FDA
is preparing to organize and operate
these records as a ‘‘system of records’’
as that term is defined by the Privacy
Act. FDA is publishing a System of
Records Notice (SORN) for this system
in the Federal Register
contemporaneous with publication of
this direct final rule.
Under the Privacy Act (5 U.S.C. 552a),
individuals have a right of access to
information pertaining to them which is
contained in a system of records. At the
same time, the Privacy Act permits
certain types of systems to be exempt
from some of the Privacy Act
requirements. For example, section
552a(k)(2) of the Privacy Act allows
Agency heads to exempt from certain
Privacy Act provisions a system of
records containing investigatory
material compiled for law enforcement
purposes. This exemption’s effect on the
record access provision is qualified in
that if the maintenance of the material
results in the denial of any right,
privilege, or benefit that the individual
would otherwise be entitled to by
Federal law, the individual must be
granted access to the material except to
the extent that the access would reveal
the identity of a source who furnished
information to the Government under an
express promise that the identity of the
source would be held in confidence. In
addition, section 552a(k)(5) of the
Privacy Act permits an Agency to
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Rules and Regulations
exempt investigatory material from
certain Privacy Act provisions where
such material is compiled solely for the
purpose of determining suitability,
eligibility, or qualifications for Federal
civilian employment, military service,
Federal contracts, or access to classified
information, but only to the extent that
the disclosure of such material would
reveal the identity of a source who
furnished information to the
Government under an express promise
that the identity of the source would be
held in confidence.
As stated previously in this
document, FDA may take administrative
action in response to a research
misconduct proceeding and, where
there is a reasonable indication that a
civil or criminal fraud may have taken
place, will refer the matter to the
appropriate investigative body. As such,
FDA scientific misconduct inquiry and
investigative files are records compiled
for law enforcement purposes, and the
subsection (k)(2) exemption is
applicable to this system of records.
Moreover, where misconduct inquiry
and investigative files are compiled
solely for the purpose of making
determinations as to the suitability for
appointment as special Government
employees or eligibility for Federal
contracts from PHS agencies, the
subsection (k)(5) exemption is
applicable.
HHS/FDA is therefore exempting this
system under subsections (k)(2) and
(k)(5) of the Privacy Act from the
notification, access and amendment
provisions of the Act (subsections (c)(3),
(d)(1) to (d)(4), (e)(4)(G) and (e)(4)(H),
and (f)). As described in the following
paragraphs, the exemptions are
necessary in order to maintain the
integrity of the research misconduct
proceedings and to ensure that the
FDA’s efforts to obtain accurate and
objective information will not be
hindered. However, consideration
would be given to requests for
notification, access, and amendment
that are addressed to FDA’s Research
Integrity Officer (System Manager) or
Privacy Act Coordinator. The specific
rationales for applying each of these
exemptions are as follows:
• Subsection (c)(3). An exemption
from the requirement to provide an
accounting of disclosures is needed
during the pendency of a research
misconduct proceeding. Release of an
accounting of disclosures to an
individual who is the subject of a
pending research misconduct
assessment, inquiry or investigation
could prematurely reveal the nature and
scope of the assessment, inquiry or
investigation and could result in the
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altering or destruction of evidence,
improper influencing of witnesses, and
other evasive actions that could impede
or compromise the proceeding.
• Subsection (d)(1). An exemption
from the access requirement is needed
both during and after a research
misconduct proceeding, to avoid
revealing the identity of any source who
was expressly promised confidentiality.
Only material that would reveal a
confidential source will be exempt from
access. Protecting the identity of a
source is necessary when the source is
unwilling to report possible research
misconduct because of fear of retaliation
(e.g., from an employer or coworkers).
• Subsections (d)(2) through (d)(4).
An exemption from the amendment
provisions is necessary while one or
more related research misconduct
proceedings are pending. Allowing
amendment of investigative records in a
pending proceeding could interfere with
that proceeding; even after that
proceeding is concluded, an amendment
could interfere with other pending or
prospective research misconduct
proceedings, or could significantly
delay inquiries or investigations in an
attempt to resolve questions of accuracy,
relevance, timeliness, and
completeness.
• Subsection (e)(4)(G) and (e)(4)(H).
An exemption from the notification
provisions is necessary during the
pendency of a research misconduct
proceeding, because notifying an
individual who is the subject of an
assessment, inquiry, or investigation of
the fact of such proceedings could
prematurely reveal the nature and scope
of the proceedings and result in the
altering or destruction of evidence,
improper influencing of witnesses, and
other evasive actions that could impede
or compromise the proceeding.
• Subsection (f). An exemption from
the requirement to establish procedures
for notification, access to records,
amendment of records, or appeals of
denials of access to records, is
appropriate because the procedures
would serve no purpose in light of the
other exemptions, to the extent that
those exemptions apply.
As stated previously in this
document, FDA’s new system of records
will be modeled after the system of
records maintained by ORI. ORI has
exempted these records under
subsections (k)(2) and (k)(5) of the
Privacy Act from the notification,
access, accounting, and amendment
provisions of the Privacy Act, to ensure
that these records will not be disclosed
inappropriately (59 FR 36717, July 19,
1994). Likewise, FDA believes that
exempting the new system, ‘‘FDA
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51911
Records Related to Research Misconduct
Proceedings, HHS/FDA,’’ from the same
Privacy Act provisions is essential to
ensure that material in FDA’s files
related to research misconduct
proceedings is not disclosed
inappropriately. Except for information
that would reveal the identity of a
source who was expressly promised
confidentiality, the access exemption
will not prohibit HHS/FDA from
granting respondents’ access requests
consistent with the PHS Policies on
Research Misconduct (42 CFR Part 93),
including in those cases in which a
finding of research misconduct has
become final and an administrative
action has been imposed.
II. Direct Final Rulemaking
FDA has determined that the subject
of this rulemaking is suitable for a direct
final rule. HHS/FDA will be
implementing a new system of records,
09–10–0020, ‘‘FDA Records Related to
Research Misconduct Proceedings,
HHS/FDA/OC.’’ HHS/FDA is exempting
this system of records from certain
requirements of the Privacy Act to
protect records compiled in the course
of scientific misconduct inquiries and
investigations and to protect the identity
of confidential sources in such
investigations. The Agency does not
anticipate receiving any significant
adverse comment on this rule.
Consistent with FDA’s procedures on
direct final rulemaking, we are
publishing elsewhere in this issue of the
Federal Register a companion proposed
rule. The companion proposed rule
provides the procedural framework
within which the rule may be finalized
in the event the direct final is
withdrawn because of any significant
adverse comment. The comment period
for this direct final rule runs
concurrently with the comment period
of the companion proposed rule. Any
comments received in response to the
companion proposed rule will also be
considered as comments regarding this
direct rule.
FDA is providing a comment period
on the direct final rule of 75 days after
the date of publication in the Federal
Register. If FDA receives any significant
adverse comment, we intend to
withdraw this direct final rule before its
effective date by publication of a notice
in the Federal Register within 30 days
after the comment period ends. A
significant adverse comment is one that
explains why the rule would be
inappropriate, including challenges to
the rule’s underlying premise or
approach, or would be ineffective or
unacceptable without a change. In
determining whether an adverse
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Rules and Regulations
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comment is significant and warrants
withdrawing a direct final rule, we will
consider whether the comment raises an
issue serious enough to warrant a
substantive response in a notice-andcomment process in accordance with
section 553 of the Administrative
Procedure Act (5 U.S.C. 553). A
comment recommending a rule change
in addition to this rule will not be
considered a significant adverse
comment unless the comment also
states why this rule would be ineffective
without the additional change.
If FDA does not receive significant
adverse comment, the Agency will
publish a document in the Federal
Register confirming the effective date of
the final rule. The Agency intends to
make the direct final rule effective 30
days after publication of the
confirmation document in the Federal
Register.
A full description of FDA’s policy on
direct final rule procedures may be
found in a guidance document
published in the Federal Register of
November 21, 1997 (62 FR 62466). The
guidance document may be accessed at
https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125166.htm.
III. Analysis of Impacts
HHS/FDA has examined the impacts
of the final rule under Executive Order
12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Orders 12866 and 13563
direct Agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The Agency
believes that this final rule is not a
significant regulatory action under
Executive Order 12866.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because the final rule imposes
no duties or obligations on small
entities, the Agency certifies that the
final rule will not have a significant
economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that Agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
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includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $136
million, using the most current (2010)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
IV. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
4. Section 5b.11 is amended by adding
paragraph (b)(2)(vii)(C) to read as
follows:
■
§ 5b.11
Exempt systems.
*
*
*
*
*
(b) * * *
(2) * * *
(vii) * * *
(C) FDA Records Related to Research
Misconduct Proceedings, HHS/FDA/OC.
*
*
*
*
*
Dated: July 20, 2012.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2012–20889 Filed 8–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
List of Subjects
[Docket Number USCG–2012–0618]
21 CFR Part 21
RIN 1625–AA00
Privacy.
45 CFR Part 5b
Privacy.
Therefore, the Department of Health
and Human Services is amending 21
CFR part 21 and 45 CFR part 5b to read
as follows:
Title 21
PART 21—PROTECTION OF PRIVACY
1. The authority citation for 21 CFR
part 21 continues to read as follows:
■
Authority: 21 U.S.C. 371; 5 U.S.C. 552,
552a.
2. Section 21.61 is amended by adding
paragraph (d) to read as follows:
■
§ 21.61
Exempt systems.
*
*
*
*
*
(d) Records in the following Food and
Drug Administration Privacy Act
Records Systems are exempt under 5
U.S.C. 552a(k)(2) and (k)(5) from the
provisions enumerated in paragraph
(a)(1) through paragraph (3) of this
section: FDA Records Related to
Research Misconduct Proceedings,
HHS/FDA/OC, 09–10–0020.
Title 45
PART 5b—PRIVACY ACT
REGULATIONS
3. The authority citation for 45 CFR
part 5b continues to read as follows:
■
Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
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Safety Zone; Tom Lyons Productions
Fireworks, Long Island Sound, Sands
Point, NY
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone on
the navigable waters of Long Island
Sound, in the vicinity of Sands Point,
NY. This temporary safety zone is
necessary to protect spectators and
vessels from the hazards associated with
fireworks displays. This rule is intended
to restrict all vessels from a portion of
Long Island Sound before, during, and
immediately after the fireworks event.
DATES: This rule will be effective from
10:30 p.m. on October 6, 2012 until
11:45 p.m. on October 7, 2012. This rule
will be enforced from 10:30 p.m. to
11:45 p.m. on October 6, 2012, and from
10:30 p.m. to 11:45 p.m. on October 7,
2012.
ADDRESSES: Documents mentioned in
this preamble are part of docket USCG–
2012–0618. To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type the docket
number in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking. You may also visit the
Docket Management Facility in Room
W12–140 on the ground floor of the
Department of Transportation West
Building, 1200 New Jersey Avenue SE.,
SUMMARY:
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Agencies
[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Rules and Regulations]
[Pages 51910-51912]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20889]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 21
[Docket No. FDA-2011-N-0252]
Office of the Secretary
45 CFR Part 5b
Privacy Act, Exempt Record System
AGENCY: Office of the Secretary, Food and Drug Administration, HHS.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) of the Department of
Health and Human Services (HHS) will be implementing a new system of
records, 09-10-0020, ``FDA Records Related to Research Misconduct
Proceedings, HHS/FDA/OC.'' HHS/FDA is exempting this system of records
from certain requirements of the Privacy Act to protect the integrity
of FDA's scientific misconduct inquiries and investigations and to
protect the identity of confidential sources in such investigations.
HHS/FDA is issuing a direct final rule for this action because the
Agency expects that there will be no significant adverse comment on
this rule.
DATES: This rule is effective January 10, 2013. Submit either
electronic or written comments by November 13, 2012. If HHS/FDA
receives no significant adverse comments within the specified comment
period, the Agency will publish a document confirming the effective
date of the final rule in the Federal Register within 30 days after the
comment period on this direct final rule ends. If timely significant
adverse comments are received, the Agency will publish a document in
the Federal Register withdrawing this direct final rule before its
effective date.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0252, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Frederick Sadler, Division of Freedom
of Information, Office of Public Information and Library Services, Food
and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-
796-8975, Frederick.Sadler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is implementing a new system of records called the ``FDA
Records Related to Research Misconduct Proceedings.'' The purpose of
this system of records is to implement FDA's responsibilities for
addressing research integrity and misconduct, in accordance with the
Public Health Service (PHS) Policies on Research Misconduct (42 CFR
part 93), for research performed by persons who are FDA employees,
agents of the Agency, or who are affiliated with the Agency by contract
or agreement. The term ``research misconduct'' is defined at 42 CFR
93.103 to mean ``fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research, or in reporting research
results.'' The general policy of the PHS Policies on Research
Misconduct is that ``Research misconduct involving PHS support is
contrary to the interests of the PHS and the Federal government and to
the health and safety of the public, to the integrity of research, and
to the conservation of public funds.'' (42 CFR 93.100(a)). The PHS
Policies on Research Misconduct provide for a number of HHS
administrative actions that can be taken in response to a research
misconduct proceeding, such as the suspension of a contract, debarment,
or an adverse personnel action against a Federal employee (42 CFR
93.407). In addition, under 42 CFR 93.401, FDA shall at any time during
a research misconduct proceeding notify HHS' Office of Research
Integrity (ORI) immediately to ensure that FDA's Office of Criminal
Investigations, HHS Office of Inspector General, the Department of
Justice, or other appropriate law enforcement agencies, are notified if
there is a reasonable indication of possible violations of civil or
criminal law.
FDA's new system of records will be modeled after the system of
records maintained by ORI, entitled ``HHS Records Related to Research
Misconduct Proceedings, HHS/OPHS/ORI'' System No. 09-37-0021 (59 FR
36717, July 19, 1994; revised most recently at 75 FR 44847, August 31,
2009).
FDA's scientific misconduct inquiry and investigation records are
located in the Office of the Chief Scientist in FDA's Office of the
Commissioner. FDA is preparing to organize and operate these records as
a ``system of records'' as that term is defined by the Privacy Act. FDA
is publishing a System of Records Notice (SORN) for this system in the
Federal Register contemporaneous with publication of this direct final
rule.
Under the Privacy Act (5 U.S.C. 552a), individuals have a right of
access to information pertaining to them which is contained in a system
of records. At the same time, the Privacy Act permits certain types of
systems to be exempt from some of the Privacy Act requirements. For
example, section 552a(k)(2) of the Privacy Act allows Agency heads to
exempt from certain Privacy Act provisions a system of records
containing investigatory material compiled for law enforcement
purposes. This exemption's effect on the record access provision is
qualified in that if the maintenance of the material results in the
denial of any right, privilege, or benefit that the individual would
otherwise be entitled to by Federal law, the individual must be granted
access to the material except to the extent that the access would
reveal the identity of a source who furnished information to the
Government under an express promise that the identity of the source
would be held in confidence. In addition, section 552a(k)(5) of the
Privacy Act permits an Agency to
[[Page 51911]]
exempt investigatory material from certain Privacy Act provisions where
such material is compiled solely for the purpose of determining
suitability, eligibility, or qualifications for Federal civilian
employment, military service, Federal contracts, or access to
classified information, but only to the extent that the disclosure of
such material would reveal the identity of a source who furnished
information to the Government under an express promise that the
identity of the source would be held in confidence.
As stated previously in this document, FDA may take administrative
action in response to a research misconduct proceeding and, where there
is a reasonable indication that a civil or criminal fraud may have
taken place, will refer the matter to the appropriate investigative
body. As such, FDA scientific misconduct inquiry and investigative
files are records compiled for law enforcement purposes, and the
subsection (k)(2) exemption is applicable to this system of records.
Moreover, where misconduct inquiry and investigative files are compiled
solely for the purpose of making determinations as to the suitability
for appointment as special Government employees or eligibility for
Federal contracts from PHS agencies, the subsection (k)(5) exemption is
applicable.
HHS/FDA is therefore exempting this system under subsections (k)(2)
and (k)(5) of the Privacy Act from the notification, access and
amendment provisions of the Act (subsections (c)(3), (d)(1) to (d)(4),
(e)(4)(G) and (e)(4)(H), and (f)). As described in the following
paragraphs, the exemptions are necessary in order to maintain the
integrity of the research misconduct proceedings and to ensure that the
FDA's efforts to obtain accurate and objective information will not be
hindered. However, consideration would be given to requests for
notification, access, and amendment that are addressed to FDA's
Research Integrity Officer (System Manager) or Privacy Act Coordinator.
The specific rationales for applying each of these exemptions are as
follows:
Subsection (c)(3). An exemption from the requirement to
provide an accounting of disclosures is needed during the pendency of a
research misconduct proceeding. Release of an accounting of disclosures
to an individual who is the subject of a pending research misconduct
assessment, inquiry or investigation could prematurely reveal the
nature and scope of the assessment, inquiry or investigation and could
result in the altering or destruction of evidence, improper influencing
of witnesses, and other evasive actions that could impede or compromise
the proceeding.
Subsection (d)(1). An exemption from the access
requirement is needed both during and after a research misconduct
proceeding, to avoid revealing the identity of any source who was
expressly promised confidentiality. Only material that would reveal a
confidential source will be exempt from access. Protecting the identity
of a source is necessary when the source is unwilling to report
possible research misconduct because of fear of retaliation (e.g., from
an employer or coworkers).
Subsections (d)(2) through (d)(4). An exemption from the
amendment provisions is necessary while one or more related research
misconduct proceedings are pending. Allowing amendment of investigative
records in a pending proceeding could interfere with that proceeding;
even after that proceeding is concluded, an amendment could interfere
with other pending or prospective research misconduct proceedings, or
could significantly delay inquiries or investigations in an attempt to
resolve questions of accuracy, relevance, timeliness, and completeness.
Subsection (e)(4)(G) and (e)(4)(H). An exemption from the
notification provisions is necessary during the pendency of a research
misconduct proceeding, because notifying an individual who is the
subject of an assessment, inquiry, or investigation of the fact of such
proceedings could prematurely reveal the nature and scope of the
proceedings and result in the altering or destruction of evidence,
improper influencing of witnesses, and other evasive actions that could
impede or compromise the proceeding.
Subsection (f). An exemption from the requirement to
establish procedures for notification, access to records, amendment of
records, or appeals of denials of access to records, is appropriate
because the procedures would serve no purpose in light of the other
exemptions, to the extent that those exemptions apply.
As stated previously in this document, FDA's new system of records
will be modeled after the system of records maintained by ORI. ORI has
exempted these records under subsections (k)(2) and (k)(5) of the
Privacy Act from the notification, access, accounting, and amendment
provisions of the Privacy Act, to ensure that these records will not be
disclosed inappropriately (59 FR 36717, July 19, 1994). Likewise, FDA
believes that exempting the new system, ``FDA Records Related to
Research Misconduct Proceedings, HHS/FDA,'' from the same Privacy Act
provisions is essential to ensure that material in FDA's files related
to research misconduct proceedings is not disclosed inappropriately.
Except for information that would reveal the identity of a source who
was expressly promised confidentiality, the access exemption will not
prohibit HHS/FDA from granting respondents' access requests consistent
with the PHS Policies on Research Misconduct (42 CFR Part 93),
including in those cases in which a finding of research misconduct has
become final and an administrative action has been imposed.
II. Direct Final Rulemaking
FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. HHS/FDA will be implementing a new system of
records, 09-10-0020, ``FDA Records Related to Research Misconduct
Proceedings, HHS/FDA/OC.'' HHS/FDA is exempting this system of records
from certain requirements of the Privacy Act to protect records
compiled in the course of scientific misconduct inquiries and
investigations and to protect the identity of confidential sources in
such investigations. The Agency does not anticipate receiving any
significant adverse comment on this rule.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule provides the procedural
framework within which the rule may be finalized in the event the
direct final is withdrawn because of any significant adverse comment.
The comment period for this direct final rule runs concurrently with
the comment period of the companion proposed rule. Any comments
received in response to the companion proposed rule will also be
considered as comments regarding this direct rule.
FDA is providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If FDA
receives any significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse
[[Page 51912]]
comment is significant and warrants withdrawing a direct final rule, we
will consider whether the comment raises an issue serious enough to
warrant a substantive response in a notice-and-comment process in
accordance with section 553 of the Administrative Procedure Act (5
U.S.C. 553). A comment recommending a rule change in addition to this
rule will not be considered a significant adverse comment unless the
comment also states why this rule would be ineffective without the
additional change.
If FDA does not receive significant adverse comment, the Agency
will publish a document in the Federal Register confirming the
effective date of the final rule. The Agency intends to make the direct
final rule effective 30 days after publication of the confirmation
document in the Federal Register.
A full description of FDA's policy on direct final rule procedures
may be found in a guidance document published in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
III. Analysis of Impacts
HHS/FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the final rule imposes no duties or
obligations on small entities, the Agency certifies that the final rule
will not have a significant economic impact on a substantial number of
small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
IV. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Part 21
Privacy.
45 CFR Part 5b
Privacy.
Therefore, the Department of Health and Human Services is amending
21 CFR part 21 and 45 CFR part 5b to read as follows:
Title 21
PART 21--PROTECTION OF PRIVACY
0
1. The authority citation for 21 CFR part 21 continues to read as
follows:
Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
0
2. Section 21.61 is amended by adding paragraph (d) to read as follows:
Sec. 21.61 Exempt systems.
* * * * *
(d) Records in the following Food and Drug Administration Privacy
Act Records Systems are exempt under 5 U.S.C. 552a(k)(2) and (k)(5)
from the provisions enumerated in paragraph (a)(1) through paragraph
(3) of this section: FDA Records Related to Research Misconduct
Proceedings, HHS/FDA/OC, 09-10-0020.
Title 45
PART 5b--PRIVACY ACT REGULATIONS
0
3. The authority citation for 45 CFR part 5b continues to read as
follows:
Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
0
4. Section 5b.11 is amended by adding paragraph (b)(2)(vii)(C) to read
as follows:
Sec. 5b.11 Exempt systems.
* * * * *
(b) * * *
(2) * * *
(vii) * * *
(C) FDA Records Related to Research Misconduct Proceedings, HHS/
FDA/OC.
* * * * *
Dated: July 20, 2012.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2012-20889 Filed 8-27-12; 8:45 am]
BILLING CODE 4160-01-P