[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]


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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: Proposed 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 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