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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
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
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:
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.
This proposed rule is a companion to the direct final rule published in the final rules section of this issue of the
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
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
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.
Interested persons may submit to the Division of Dockets Management (see
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:
1. The authority citation for 21 CFR part 21 continues to read as follows:
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:
(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.
3. The authority citation for 45 CFR part 5b continues to read as follows:
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:
(b) * * *
(2) * * *
(vii) * * *
(C) FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.