Daily Rules, Proposed Rules, and Notices of the Federal Government
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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 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
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:
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.
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
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
If FDA does not receive significant adverse comment, the Agency will publish a document in the
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 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.
Interested persons may submit to the Division of Dockets Management (see
Therefore, the Department of Health and Human Services is amending 21 CFR part 21 and 45 CFR part 5b to read as follows:
21 U.S.C. 371; 5 U.S.C. 552, 552a.
(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.
5 U.S.C. 301, 5 U.S.C. 552a.
(b) * * *
(2) * * *
(vii) * * *
(C) FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.