Privacy Act; Implementation, 51954-51957 [2012-20887]
Download as PDF
<![CDATA[
51954
Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Proposed Rules
9. Civil Justice Reform
This proposed rule meets applicable
standards in sections 3(a) and 3(b)(2) of
Executive Order 12988, Civil Justice
Reform, to minimize litigation,
eliminate ambiguity, and reduce
burden.
10. Protection of Children From
Environmental Health Risks
We have analyzed this proposed rule
under Executive Order 13045,
Protection of Children from
Environmental Health Risks and Safety
Risks. This rule is not an economically
significant rule and would not create an
environmental risk to health or risk to
safety that might disproportionately
affect children.
11. Indian Tribal Governments
This proposed rule does not have
tribal implications under Executive
Order 13175, Consultation and
Coordination with Indian Tribal
Governments, because it would not have
a substantial direct effect on one or
more Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
12. Energy Effects
This proposed rule is not a
‘‘significant energy action’’ under
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use because it is not a
‘‘significant regulatory action’’ under
Executive Order 12866 and is not likely
to have a significant adverse effect on
the supply, distribution, or use of
energy. The Administrator of the Office
of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
13. Technical Standards
This proposed rule does not use
technical standards. Therefore, we did
not consider the use of voluntary
consensus standards.
14. Environment
We have analyzed this rule under
Department of Homeland Security
Management Directive 023–01 and
Commandant Instruction M16475.lD,
which guide the Coast Guard in
complying with the National
Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321–4370f), and
have concluded this action is one of a
category of actions which do not
individually or cumulatively have a
significant effect on the human
environment. This rule is categorically
excluded, under figure 2–1, paragraph
(34)(h), of the Instruction. This rule
involves implementation of regulations
within 33 CFR Part 100 that apply to
organized marine events on the
navigable waters of the United States
that may have potential for negative
impact on the safety or other interest of
waterway users and shore side activities
in the event area. The category of water
activities includes but is not limited to
sail boat regattas, boat parades, power
boat racing, swimming events, crew
racing, and sail board racing. Under
figure 2–1, paragraph (34)(h), of the
Instruction, an environmental analysis
checklist and a categorical exclusion
determination will be available in the
docket where indicated under
ADDRESSES.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water),
Reporting and recordkeeping
requirements, Waterways.
For the reasons discussed in the
preamble, the Coast Guard proposes to
amend 33 CFR part 100 as follows:
PART 100—SAFETY OF LIFE ON
NAVIGABLE WATERS
1. The authority citation for part 100
continues to read as follows:
Authority: 33 U.S.C. 1233.
2. In § 100.501, in the Table to
§ 100.501, temporarily suspend line
(c)19.
3. In § 100.501, in the Table to
§ 100.510, add temporary line 23 to read
as follows:
§ 100.501 Special Local Regulations;
Marine Events in the Fifth Coast Guard
District.
*
*
*
*
*
(C.) COAST GUARD SECTOR HAMPTON ROADS—COTP ZONE
No.
23 .....
Date
*
*
September 30, 2012 or in
the case of inclement
weather October 7,
2012.
*
srobinson on DSK4SPTVN1PROD with PROPOSALS
Event
Sponsor
*
Poquoson Seafood Festival Workboat Races.
*
*
*
*
*
City of Poquoson ............ The waters of the Back River, Poquoson, Virginia,
bounded on the north by a line drawn along latitude 37°06′30″ N, bounded on the south by a
line drawn along latitude 37°06′15″ N, bounded
on the east by a line drawn along longitude
076°18′52″ W and bounded on the west by a line
drawn along longitude 076°19′30″ W.
*
Dated: August 1, 2012.
John K. Little,
Captain, U.S. Coast Guard, Captain of the
Port Hampton Roads.
Location
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 5b
[FR Doc. 2012–21211 Filed 8–27–12; 8:45 am]
[Docket Number NIH–2011–0001]
BILLING CODE 9110–04–P
Privacy Act; Implementation
Department of Health and
Human Services.
ACTION: Notice of proposed rulemaking.
AGENCY:
VerDate Mar<15>2010
16:27 Aug 27, 2012
Jkt 226001
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
*
*
The Department of Health and
Human Services (HHS or Department),
through the National Institutes of Health
(NIH), is implementing a new system of
records, 09–25–0223, ‘‘NIH Records
Related to Research Misconduct
Proceedings, HHS/NIH.’’ HHS is
exempting this system of records from
certain requirements of the Privacy Act
to protect the integrity of NIH research
misconduct proceedings and to protect
the identity of confidential sources in
SUMMARY:
E:\FR\FM\28AUP1.SGM
28AUP1
Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Proposed Rules
such proceedings. Elsewhere in this
issue of the Federal Register, HHS is
issuing a direct final rule for this action
because the agency expects that there
will be no significant adverse comment
on this rule. HHS is publishing this
companion proposed rule under the
agency’s usual procedure for notice-andcomment rulemaking, to provide a
procedural framework to finalize the
rule in the event the agency publishing
this companion proposed rule under the
agency’s usual procedure for notice-andcomment rulemaking, to provide a
procedural framework to finalize the
rule in the event the agency receives any
significant comments and withdraws
the direct final rule. The direct final rule
and this companion proposed rule are
substantively identical.
DATES: Submit either electronic or
written comments by November 13,
2012. If HHS/NIH receives any
significant adverse comments, the
agency will publish withdrawing the
direct final rule within 30 days after the
comment period ends. HHS/NIH will
then proceed to respond to comments
under this proposed rule using the usual
notice and comment procedures.
ADDRESSES: You may submit comments,
identified by [Docket No(s).], 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.
srobinson on DSK4SPTVN1PROD with PROPOSALS
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–402–0169.
• Mail: Jerry Moore, NIH Regulations
Officer, Office of Management
Assessment, National Institutes of
Health, 6011 Executive Boulevard, Suite
601, MSC 7669, Rockville, MD 20852–
7669.
To ensure a more timely processing of
comments, HHS/NIH is no longer
accepting comments submitted to the
agency by email. HHS/NIH encourages
you to continue to submit electronic
comments by using the Federal
eRulemaking Portal, as described
previously, in the ADDRESSES portion of
this document under Electronic
Submissions.
Instructions: All submissions received
must include the agency name and
Docket No. for this rulemaking. All
comments received may be posted
without change to https://www.
regulations.gov, including any personal
information provided.
VerDate Mar<15>2010
16:27 Aug 27, 2012
Jkt 226001
Docket: For access to the docket to
read background documents or
comments received, go to https://www.
regulations.gov and follow the
instructions provided for conducting a
search, using the docket number(s)
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jerry
Moore, NIH Regulations Officer, Office
of Management Assessment, National
Institutes of Health, 6011 Executive
Boulevard, Suite 601, MSC 7669,
Rockville, MD 20852–7669, telephone
301–496–4607, fax 301–402–0169, email
jm40z@nih.gov.
SUPPLEMENTARY INFORMATION: NIH is
implementing a new system of records
called, ‘‘NIH Records Related to
Research Misconduct Proceedings’’ (09–
25–0223). This system of records is part
of NIH’s implementation of its
responsibilities under the Public Health
Service (PHS) Policies on Research
Misconduct, 42 CFR part 93. The system
notice applies to alleged or actual
research misconduct involving research:
(1) Carried out in NIH facilities by any
person; (2) funded by the NIH
Intramural Research Program (IRP) in
any location; or (3) undertaken by an
NIH employee or trainee as part of his
or her official NIH duties or NIH
training activities, regardless of location.
A person who, at the time of the alleged
or actual research misconduct, was
employed by, was an agent of, or was
affiliated by contract, agreement, or
other arrangement with NIH, is covered
by the system if, for example, he or she
is involved in: (1) NIH- or PHSsupported biomedical or behavioral
research; (2) NIH- or PHS-supported
biomedical or behavioral research
training programs; (3) NIH- or PHSsupported activities that are related to
biomedical or behavioral research or
research training, such as the operation
of tissue and data banks and the
dissemination of research information;
(4) plagiarism of research records
produced in the course of NIH- or PHSsupported research, research training or
activities related to that research or
research training; or (5) an application
or proposal for NIH or PHS support for
biomedical or behavioral research,
research training or activities related to
that research or research training, such
as the operation of tissue and data banks
and the dissemination of research
information (regardless of whether it is
approved or funded).
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
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
51955
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 an
adverse personnel action against a
federal employee, the suspension of a
contract, or debarment. 42 CFR 93.407.
In addition, pursuant to 42 CFR 93.318
and 93.401, NIH shall at any time
during a research misconduct
proceeding notify the HHS Office of
Research Integrity (ORI) immediately to
ensure that NIH’s Office of Management
Assessment, HHS’ Office of Inspector
General, the Department of Justice, or
other appropriate law enforcement
agencies are notified and consulted, if
there is a reasonable indication of
possible violations of civil or criminal
law that may involve such offices.
NIH’s system of records is modeled
after the system of records maintained
by ORI, entitled ‘‘HHS Records Related
to Research Misconduct Proceedings,
HHS/OS/ORI’’ System No. 09–37–0021
(59 FR 36717, July 19, 1994; revised
most recently at 74 FR 44847, Aug. 31,
2009).
NIH’s records related to research
misconduct proceedings are located in
the Office of Intramural Research in
NIH’s Office of the Director. NIH is
updating its organization and operation
of these records, to be exempt from
Privacy Act requirements, as provided
in the direct final rule and in a new
‘‘System of Records Notice’’ which NIH
is publishing in the Federal Register for
public comment contemporaneously
with or soon after publication of this
companion proposed 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 Act permits certain types
of systems to be exempt from some of
the Privacy Act requirements, including
the access requirement. For example,
section 552a(k)(2) 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 access
requirement is qualified in that if the
maintenance of the material results in
the denial of any right, privilege, or
benefit that the individual would be
otherwise entitled to by Federal law, the
E:\FR\FM\28AUP1.SGM
28AUP1
srobinson on DSK4SPTVN1PROD with PROPOSALS
51956
Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Proposed Rules
individual must be granted access to the
material unless the access would reveal
the identity of a source who furnished
information to the Government under an
express promise of confidentiality. In
addition, section 552a(k)(5) permits an
agency to 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 above, NIH may take
administrative action in response to a
research misconduct proceeding and,
where a civil or criminal fraud may
have taken place, NIH may refer the
matter to the appropriate investigative
body. As such, NIH’s records related to
research misconduct proceedings are
compiled for law enforcement purposes,
and the subsection (k)(2) exemption is
applicable to this system of record.
Moreover, where records related to
research misconduct proceedings 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.
Exempting the system from Privacy
Act provisions pertaining to providing
an accounting of disclosures, access and
amendment, notification, and
procedures and rules is necessary to
maintain the integrity of the research
misconduct proceedings and to ensure
that the NIH’s efforts to obtain accurate
and objective information will not be
hindered.
Accordingly, HHS/NIH is exempting
this system under subsections (k)(2) and
(k)(5) of the Privacy Act from the
accounting, access, and amendment,
notification and procedures and rules
provisions of the Privacy Act
(paragraphs (c)(3), (d)(1)–(4), (e)(4)(G)
and (H), and (f)) for the reasons stated
below. However, consideration will be
given to requests for notification, access,
and amendment that are addressed to
the System Manager. The specific
rationale for exempting the system from
each of these provisions is 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
VerDate Mar<15>2010
16:27 Aug 27, 2012
Jkt 226001
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 come forward and report
possible research misconduct because of
fear of retaliation (e.g., from an
employee or co-worker).
• 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.
• Subsections (e)(4)(G) and (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 in a manner that
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 (f). An exemption from
this requirement to establish procedures
for notification, access to records,
amendment of records, or appeals of
denials of access to records, is necessary
because the procedures would serve no
purpose in light of the other
exemptions, to the extent that those
exemptions apply.
As stated above, NIH’s system of
records is modeled after the system of
records maintained by HHS’ Office of
Research Integrity (ORI). ORI has
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
exempted these records under
subsections (k)(2) and (k)(5) of the
Privacy Act from the notification,
accounting, access, and amendment
provisions of the Privacy Act, to ensure
that these investigative files will not be
disclosed inappropriately [59 FR 36717
(July 19, 1994)]. Likewise, NIH believes
that exempting the new system, ‘‘NIH
Records Related to Research Misconduct
Proceedings, HHS/NIH,’’ from the
Privacy Act provisions is essential to
ensure that material in NIH’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/NIH 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.
Analysis of Impacts
HHS/NIH has examined the impacts
of the final rule under Executive Order
12866 and the Regulatory Flexibility Act
(5 U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). Executive Order 12866 directs
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 the final rule is not
a significant regulatory action under the
Executive Order.
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
E:\FR\FM\28AUP1.SGM
28AUP1
Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Proposed Rules
million, using the most current (2010)
Implicit Price Deflator for the Gross
Domestic Product. NIH does not expect
that a final rule consistent with this
NPRM would result in any 1-year
expenditure that would meet or exceed
this amount.
List of Subjects in 45 CFR Part 5b
Privacy.
For the reasons set out in the
preamble, the Department proposes to
amend its Privacy Act Regulations, Part
5b of 45 CFR Subtitle A, as follows:
PART 5b—PRIVACY ACT
REGULATIONS
1. The authority citation for Part 5b
continues to read as follows:
Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
2. In § 5b.11, add paragraph
(b)(2)(vii)(D) to read as follows:
§ 5b.11
Exempt systems
*
*
*
*
*
(b) * * *
(2) * * *
(vii) * * *
(D) NIH Records Related to Research
Misconduct Proceedings, HHS/NIH, 09–
25–0223.
Dated: July 20, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2012–20887 Filed 8–27–12; 8:45 am]
BILLING CODE 4140–01–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 204
RIN 0750–AH80
Defense Federal Acquisition
Regulation Supplement: Clarification
of ‘‘F’’ Orders in the Procurement
Instrument Identification Number
Structure (DFARS Case 2012–D040)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Proposed rule.
srobinson on DSK4SPTVN1PROD with PROPOSALS
AGENCY:
DoD is proposing to amend
the Defense Federal Acquisition
Regulation Supplement (DFARS) to
update instructions for assigning basic
and supplementary procurement
instrument identification numbers.
DATES: Comments on the proposed rule
should be submitted in writing to the
address shown below on or before
SUMMARY:
VerDate Mar<15>2010
16:27 Aug 27, 2012
Jkt 226001
October 29, 2012, to be considered in
the formation of a final rule.
ADDRESSES: Submit comments
identified by DFARS Case 2012–D040,
using any of the following methods:
Æ Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
entering ‘‘DFARS Case 2012–D040’’
under the heading ‘‘Enter keyword or
ID’’ and selecting ‘‘Search.’’ Select the
link ‘‘Submit a Comment’’ that
corresponds with ‘‘DFARS Case 2012–
D040.’’ Follow the instructions provided
at the ‘‘Submit a Comment’’ screen.
Please include your name, company
name (if any), and ‘‘DFARS Case 2012–
D040’’ on your attached document.
Æ Email: dfars@osd.mil. Include
DFARS Case 2012–D040 in the subject
line of the message.
Æ Fax: 571–372–6094.
Æ Mail: Defense Acquisition
Regulations System, Attn: Veronica
Fallon, OUSD(AT&L)DPAP/DARS,
Room 3B855, 3060 Defense Pentagon,
Washington, DC 20301–3060.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal information provided. To
confirm receipt of your comment(s),
please check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT:
Veronica Fallon, telephone 571–372–
6087.
I. Background
DoD is proposing to revise the DFARS
to eliminate the requirement to utilize
an ‘‘F’’ in the 9th position of the
procurement instrument identification
number (PIIN) to identify awards to
certain vendors, including AbilityOne
and Federal Prison Industries
(UNICOR), and to other Government
organizations. These vendors are
uniquely identified today by their
DUNS number and/or CAGE code and,
therefore, associated contract actions are
easily tracked. There is no longer any
need for DoD to uniquely identify
contract actions with these vendors.
Under the proposed rule, contract
actions with these vendors will be
treated and identified in the same
manner as those with any other vendor.
This change proposes to limit the use of
‘‘F’’ in the 9th position of the PIIN to
those task and delivery orders issued
under a non-DoD issued contract or
agreement. It is anticipated that this
proposed change, which further
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
51957
standardizes DoD procedures, will also
reduce data errors and interoperability
problems throughout the Department’s
business processes.
II. Discussion and Analysis
DoD is proposing the following
changes to the DFARS:
• Revise 204.7003, Basic PII number,
paragraph (a)(3), Position 9, by—
—Deleting from subparagraph (iii)
instrument type C, the exception for
contracts placed with or through other
Government departments or agencies;
—Deleting from subparagraph (vi)
instrument type F, contracting actions
placed with or through other
Government departments or agencies
or against contracts placed by such
departments or agencies outside the
DoD (including actions from nonprofit
agencies employing people who are
blind or severely disabled
(AbilityOne), and the Federal Prison
Industries (UNICOR));
—Providing at subparagraph (vi)
instrument type F direction for its use
with blanket purchase agreement
calls, orders under contracts,
including Federal Supply Schedules,
Governmentwide acquisition
contracts, and multi-agency contracts,
basic ordering agreements issued by
departments or agencies outside of
DoD; and
• Revising 204.7004, Supplementary PII
numbers, paragraph (d)(2)(ii) by
providing direction to use ‘‘F’’ in
position 9 for calls against blanket
purchase agreements and orders
placed under non-DoD issued
contracts including Federal Supply
Schedules, Governmentwide
acquisition contracts, and multiagency contracts, or basic ordering
agreements. The proposed text also
directs that a supplementary PII
number with an ‘‘F’’ in the 9th
position is to be used only once, and
not for more than one order.
III. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and
13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This is not a significant
regulatory action and, therefore, was not
subject to review under section 6(b) of
E.O. 12866, Regulatory Planning and
E:\FR\FM\28AUP1.SGM
28AUP1
]]>Agencies
[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Proposed Rules]
[Pages 51954-51957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20887]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 5b
[Docket Number NIH-2011-0001]
Privacy Act; Implementation
AGENCY: Department of Health and Human Services.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS or
Department), through the National Institutes of Health (NIH), is
implementing a new system of records, 09-25-0223, ``NIH Records Related
to Research Misconduct Proceedings, HHS/NIH.'' HHS is exempting this
system of records from certain requirements of the Privacy Act to
protect the integrity of NIH research misconduct proceedings and to
protect the identity of confidential sources in
[[Page 51955]]
such proceedings. Elsewhere in this issue of the Federal Register, HHS
is issuing a direct final rule for this action because the agency
expects that there will be no significant adverse comment on this rule.
HHS is publishing this companion proposed rule under the agency's usual
procedure for notice-and-comment rulemaking, to provide a procedural
framework to finalize the rule in the event the agency publishing this
companion proposed rule under the agency's usual procedure for notice-
and-comment rulemaking, to provide a procedural framework to finalize
the rule in the event the agency receives any significant comments and
withdraws the direct final rule. The direct final rule and this
companion proposed rule are substantively identical.
DATES: Submit either electronic or written comments by November 13,
2012. If HHS/NIH receives any significant adverse comments, the agency
will publish withdrawing the direct final rule within 30 days after the
comment period ends. HHS/NIH will then proceed to respond to comments
under this proposed rule using the usual notice and comment procedures.
ADDRESSES: You may submit comments, identified by [Docket No(s).], 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: 301-402-0169.
Mail: Jerry Moore, NIH Regulations Officer, Office of
Management Assessment, National Institutes of Health, 6011 Executive
Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669.
To ensure a more timely processing of comments, HHS/NIH is no
longer accepting comments submitted to the agency by email. HHS/NIH
encourages you to continue to submit electronic comments by using the
Federal eRulemaking Portal, as described previously, in the ADDRESSES
portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and follow the
instructions provided for conducting a search, using the docket
number(s) found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, National Institutes of Health, 6011
Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669,
telephone 301-496-4607, fax 301-402-0169, email jm40z@nih.gov.
SUPPLEMENTARY INFORMATION: NIH is implementing a new system of records
called, ``NIH Records Related to Research Misconduct Proceedings'' (09-
25-0223). This system of records is part of NIH's implementation of its
responsibilities under the Public Health Service (PHS) Policies on
Research Misconduct, 42 CFR part 93. The system notice applies to
alleged or actual research misconduct involving research: (1) Carried
out in NIH facilities by any person; (2) funded by the NIH Intramural
Research Program (IRP) in any location; or (3) undertaken by an NIH
employee or trainee as part of his or her official NIH duties or NIH
training activities, regardless of location. A person who, at the time
of the alleged or actual research misconduct, was employed by, was an
agent of, or was affiliated by contract, agreement, or other
arrangement with NIH, is covered by the system if, for example, he or
she is involved in: (1) NIH- or PHS-supported biomedical or behavioral
research; (2) NIH- or PHS-supported biomedical or behavioral research
training programs; (3) NIH- or PHS-supported activities that are
related to biomedical or behavioral research or research training, such
as the operation of tissue and data banks and the dissemination of
research information; (4) plagiarism of research records produced in
the course of NIH- or PHS-supported research, research training or
activities related to that research or research training; or (5) an
application or proposal for NIH or PHS support for biomedical or
behavioral research, research training or activities related to that
research or research training, such as the operation of tissue and data
banks and the dissemination of research information (regardless of
whether it is approved or funded).
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 an adverse personnel action against a federal employee, the
suspension of a contract, or debarment. 42 CFR 93.407. In addition,
pursuant to 42 CFR 93.318 and 93.401, NIH shall at any time during a
research misconduct proceeding notify the HHS Office of Research
Integrity (ORI) immediately to ensure that NIH's Office of Management
Assessment, HHS' Office of Inspector General, the Department of
Justice, or other appropriate law enforcement agencies are notified and
consulted, if there is a reasonable indication of possible violations
of civil or criminal law that may involve such offices.
NIH's system of records is modeled after the system of records
maintained by ORI, entitled ``HHS Records Related to Research
Misconduct Proceedings, HHS/OS/ORI'' System No. 09-37-0021 (59 FR
36717, July 19, 1994; revised most recently at 74 FR 44847, Aug. 31,
2009).
NIH's records related to research misconduct proceedings are
located in the Office of Intramural Research in NIH's Office of the
Director. NIH is updating its organization and operation of these
records, to be exempt from Privacy Act requirements, as provided in the
direct final rule and in a new ``System of Records Notice'' which NIH
is publishing in the Federal Register for public comment
contemporaneously with or soon after publication of this companion
proposed 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 Act permits certain types of systems
to be exempt from some of the Privacy Act requirements, including the
access requirement. For example, section 552a(k)(2) 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 access requirement is
qualified in that if the maintenance of the material results in the
denial of any right, privilege, or benefit that the individual would be
otherwise entitled to by Federal law, the
[[Page 51956]]
individual must be granted access to the material unless the access
would reveal the identity of a source who furnished information to the
Government under an express promise of confidentiality. In addition,
section 552a(k)(5) permits an agency to 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 above, NIH may take administrative action in response to
a research misconduct proceeding and, where a civil or criminal fraud
may have taken place, NIH may refer the matter to the appropriate
investigative body. As such, NIH's records related to research
misconduct proceedings are compiled for law enforcement purposes, and
the subsection (k)(2) exemption is applicable to this system of record.
Moreover, where records related to research misconduct proceedings 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.
Exempting the system from Privacy Act provisions pertaining to
providing an accounting of disclosures, access and amendment,
notification, and procedures and rules is necessary to maintain the
integrity of the research misconduct proceedings and to ensure that the
NIH's efforts to obtain accurate and objective information will not be
hindered.
Accordingly, HHS/NIH is exempting this system under subsections
(k)(2) and (k)(5) of the Privacy Act from the accounting, access, and
amendment, notification and procedures and rules provisions of the
Privacy Act (paragraphs (c)(3), (d)(1)-(4), (e)(4)(G) and (H), and (f))
for the reasons stated below. However, consideration will be given to
requests for notification, access, and amendment that are addressed to
the System Manager. The specific rationale for exempting the system
from each of these provisions is 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 come forward
and report possible research misconduct because of fear of retaliation
(e.g., from an employee or co-worker).
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.
Subsections (e)(4)(G) and (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 in a manner that 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 (f). An exemption from this requirement to
establish procedures for notification, access to records, amendment of
records, or appeals of denials of access to records, is necessary
because the procedures would serve no purpose in light of the other
exemptions, to the extent that those exemptions apply.
As stated above, NIH's system of records is modeled after the
system of records maintained by HHS' Office of Research Integrity
(ORI). ORI has exempted these records under subsections (k)(2) and
(k)(5) of the Privacy Act from the notification, accounting, access,
and amendment provisions of the Privacy Act, to ensure that these
investigative files will not be disclosed inappropriately [59 FR 36717
(July 19, 1994)]. Likewise, NIH believes that exempting the new system,
``NIH Records Related to Research Misconduct Proceedings, HHS/NIH,''
from the Privacy Act provisions is essential to ensure that material in
NIH'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/NIH 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.
Analysis of Impacts
HHS/NIH has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs 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
the final rule is not a significant regulatory action under the
Executive Order.
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
[[Page 51957]]
million, using the most current (2010) Implicit Price Deflator for the
Gross Domestic Product. NIH does not expect that a final rule
consistent with this NPRM would result in any 1-year expenditure that
would meet or exceed this amount.
List of Subjects in 45 CFR Part 5b
Privacy.
For the reasons set out in the preamble, the Department proposes to
amend its Privacy Act Regulations, Part 5b of 45 CFR Subtitle A, as
follows:
PART 5b--PRIVACY ACT REGULATIONS
1. The authority citation for Part 5b continues to read as follows:
Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
2. In Sec. 5b.11, add paragraph (b)(2)(vii)(D) to read as follows:
Sec. 5b.11 Exempt systems
* * * * *
(b) * * *
(2) * * *
(vii) * * *
(D) NIH Records Related to Research Misconduct Proceedings, HHS/
NIH, 09-25-0223.
Dated: July 20, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-20887 Filed 8-27-12; 8:45 am]
BILLING CODE 4140-01-P
