[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Rules and Regulations]
[Pages 39184-39186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15599]


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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; Implementation

AGENCY: Office of the Secretary, Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) of the 
Department of Health and Human Services (HHS or Department) is 
exempting a system of records from certain requirements of the Privacy 
Act to protect the integrity of FDA's scientific research misconduct 
proceedings and to protect the identity of confidential sources in such 
proceedings.

DATES: This rule is effective July 31, 2013.

FOR FURTHER INFORMATION CONTACT: Frederick Sadler, Division of Freedom 
of Information, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-8975, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    HHS/FDA is exempting a system of records, 09-10-0020, ``FDA Records 
Related to Research Misconduct Proceedings, HHS/FDA/OC,'' under 
subsections (k)(2) and (k)(5) of the Privacy Act (5 U.S.C. 552a) from 
notification, access, accounting, and amendment provisions of the 
Privacy Act.
    The purpose of this system of records is to implement FDA's 
responsibilities under 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)).
    Under the Privacy Act, 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 (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. This exemption is also limited as it 
will be applied 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 of confidentiality.
    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'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 records. 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.
    On August 28, 2012, HHS/FDA published a system of records notice 
(SORN) for this system (77 FR 52036). On the same date, HHS/FDA also 
published a proposed rule (77 FR 51949) and, anticipating no 
significant adverse comment, a direct final rule (77 FR 51910) to 
exempt this system of records under subsections (k)(2) and (k)(5) of 
the Privacy Act from the notification, access, accounting, and 
amendment provisions of the Privacy Act. The comment period was open 
through November 13, 2012. The Agency received three comments regarding 
the exemptions. One comment was positive and in favor of the 
exemptions. Another comment appears to have misunderstood the scope and 
applicability of the exceptions, because it assumed that the purpose of 
the rule was to exempt these records from access by the general public. 
The third comment broadly opposed the exemptions as a governmental 
over-reach restricting citizens' ability to maintain awareness of the 
actions of regulatory bodies. FDA construed this last comment as 
sufficiently adverse to merit withdrawal of the direct final rule on 
January 10, 2013 (78 FR 2892; January 15, 2013). HHS/FDA now publishes 
this final rule under the

[[Page 39185]]

standard notice and comment rulemaking process.
    After considering the comments, HHS/FDA believes the exemptions at 
issue are necessary to fulfill the Agency's responsibilities for 
addressing research misconduct. The exemptions are essential in order 
for FDA to protect the confidentiality of sources who provide 
information relevant to a research misconduct proceeding and to guard 
against the premature disclosure of research misconduct records that 
might obstruct or compromise proceedings. The exemptions will thereby 
enable FDA to maintain the integrity and effectiveness of research 
misconduct proceedings.
    Failure to adopt the exemptions would jeopardize the integrity and 
effectiveness of FDA's research misconduct proceedings. FDA's new 
system of records is modeled after the system of records maintained by 
HHS' Office of Research Integrity (ORI) entitled ``HHS Records Related 
to Research Misconduct Proceedings, HHS/OS/ORI'' System No. 09-37-0021 
(59 FR 36776, July 19, 1994; revised most recently at 74 FR 44847, 
August 31, 2009). 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). 
Likewise, HHS/FDA believes that exempting the new FDA system 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.
    Subject to its obligations under the PHS Policies on Research 
Misconduct, 42 CFR Part 93, and other applicable law, 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 Privacy Act (subsections (c)(3), (d)(1) to (d)(4), (e)(4)(G) and 
(e)(4)(H), and (f)). The specific rationales for applying each of the 
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 
Privacy Act 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. This exemption does not alter 
FDA's obligations to provide notice to the respondent in a research 
misconduct proceeding as described in the PHS Policies on Research 
Misconduct, 42 CFR Part 93.
     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.
    To avoid the unnecessary application of the exemptions, FDA will 
give case-by-case consideration to requests for notification, access, 
and amendment submitted to FDA's Research Integrity Officer (System 
Manager) or Privacy Act Coordinator. 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. The request submission process 
is described in the SORN previously published for this system (77 FR 
52036) and available online at http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/ucm323341.htm.

II. 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 $139 million, using the most current (2011) Implicit 
Price Deflator for the Gross Domestic Product. HHS/FDA does not expect 
this final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

[[Page 39186]]

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 
(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

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, 09-10-0020.
* * * * *

    Dated: June 14, 2013.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2013-15599 Filed 6-28-13; 8:45 am]
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