[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Proposed Rules]
[Pages 51949-51951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20890]
=======================================================================
-----------------------------------------------------------------------
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: Proposed 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 proposes to exempt 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.
DATES: Submit either electronic or written comments by November 13,
2012. If HHS/FDA receives any significant adverse comments, the Agency
will publish a document withdrawing the direct final rule within 30
days after the comment period ends. HHS/FDA 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. FDA-2011-
N-0252, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://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 http://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 http://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 & 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 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 Privacy Act permits certain types of
systems to be exempt
[[Page 51950]]
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 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 proposing to exempt 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
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. Companion Document to Direct Final Rulemaking
This proposed rule is a companion to the direct final rule
published in the final rules section of this issue of the Federal
Register. The direct final rule and this companion proposed rule are
substantively identical. This companion proposed rule provides the
procedural framework to proceed with standard notice-and-comment
rulemaking if the direct final rule receives significant adverse
comment and is withdrawn. FDA is publishing the direct final rule
because we believe the rule is noncontroversial and we do not
anticipate receiving any significant adverse comments.
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 comment is significant and
warrants terminating a direct final rulemaking, we will consider
whether the comment
[[Page 51951]]
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). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered significant or adverse under this procedure. A comment
recommending a regulation change in addition to those in the rule would
not be considered a significant adverse comment unless the comment
states why the rule would be ineffective without the additional change.
In addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of a significant adverse comment.
The comment period for the companion proposed rule runs concurrently
with the comment period of the direct final rule. Any comments received
on this companion proposed rule will also be treated as comments on the
direct final rule. We will not provide additional opportunity for
comment.
If no significant adverse comment is received in response to the
direct final rule, no further action will be taken related to this
companion proposed rule. Instead, we will publish a document confirming
the effective date within 30 days after the comment period ends, and we
intend the direct final rule to become effective 30 days after
publication of the confirmation notice.
If FDA receives any significant adverse comments, the Agency will
withdraw the direct final rule within 30 days after the comment period
ends and proceed to respond to all of the comments under this companion
proposed rule using usual notice-and-comment rulemaking procedures. The
Agency will address the comments in a subsequent final rule.
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: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
III. Analysis of Impacts
HHS/FDA has examined the impacts of the proposed 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
proposed 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 proposed rule imposes no duties or
obligations on small entities, the Agency proposes to certify that the
final rule would 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
proposed 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 proposing
to amend 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:
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
(a)(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.
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. 2012-20890 Filed 8-27-12; 8:45 am]
BILLING CODE 4160-01-P