
[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]


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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

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

ACTION: Direct final rule.

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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: 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 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

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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-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 http://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


