80 FR 49138 - Program Fraud Civil Remedies
DEPARTMENT OF STATE Federal Register Volume 80, Issue 158 (August 17, 2015)
Federal Register Volume 80, Issue 158 (August 17, 2015)
| Page Range | 49138-49140 | |
| FR Document | 2015-20263 |
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)] [Rules and Regulations] [Pages 49138-49140] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20263] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF STATE 22 CFR Part 35 [Public Notice 9220] RIN 1400-AD85 Program Fraud Civil Remedies AGENCY: Department of State. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Department of State is updating its regulations regarding its implementation of the Program Fraud Civil Remedies Act of 1986, to remove a conflict between the ``reviewing official'' and the ``authority head'' as defined by the implementing regulations. DATES: This rule is effective August 17, 2015. FOR FURTHER INFORMATION CONTACT: Alice Kottmyer, Attorney-Adviser, [[Page 49139]] Office of the Legal Adviser, (202) 647-2318, or [email protected]. SUPPLEMENTARY INFORMATION: The Program Fraud Civil Remedies Act of 1986, 31 U.S.C. 3801 et seq. (the Act), outlines a procedure for establishing administrative procedures for imposing civil penalties and assessments against persons who make, submit, or present, or cause to be made, submitted, or presented, false fictitious, or fraudulent claims or written statements to authorities or to their agents; and specifying the hearing and appeal rights of persons subject to allegations of liability for such penalties and assessments. In a nutshell, the ``investigating official'' (who is in the Office of the Inspector General) presents a case to the ``reviewing official'' (currently defined as the Chief Financial Officer) who, if appropriate, forwards the case to the Department of Justice. The Department of Justice will approve a ``claim'' if it believes further action is warranted. The reviewing official serves the claim on the respondent. There is a hearing before an administrative law judge (ALJ), and a disposition adverse to the respondent can be appealed to the ``authority head,'' defined in the rule as the Under Secretary for Management. Currently, the Under Secretary for Management is designated by the President as the Chief Financial Officer for the Department of State. Therefore, he is the reviewing official as well as the authority head, which of course is unacceptable. This rule corrects that anomaly, by defining the ``reviewing official'' as the Assistant Legal Adviser for Buildings and Acquisitions (hereinafter, ``the ALA''). The Under Secretary for Management remains the authority head. The Act (in 31 U.S.C. 3801(a)(8)) outlines the qualifications for the reviewing official, all of which are met by the ALA. (1) He or she must be designated by the authority head to make the determination under 31 U.S.C. 3803(a)(2) to send the case to the Department of Justice for its review and action, if appropriate. (2) He or she must be serving in a position for which the rate of basic pay is not less than the minimum rate of basic pay for grade GS-16 under the General Schedule; the ALA is a member of the Senior Executive Service, and thus has a rate of pay at least as high as GS-16, a grade which was eliminated under the provisions of the Civil Service Reform Act of 1978. (3) He or she must not be subject to supervision by, or required to report to, the investigating official, and not employed in the organizational unit of the authority in which the investigating official is employed; the ALA is not in the Office of the Inspector General and is not (nor will he or she ever be) subject to the supervision of anyone in that office. Accordingly, 22 CFR 35.2(r), the definition of ``reviewing official,'' is changed by this rulemaking. Regulatory Findings Administrative Procedure Act This regulation amends a ``rule of agency organization, procedure, or practice'', which is not subject to the notice-and-comment rulemaking procedures set forth in 5 U.S.C. 553. See 5 U.S.C. 553(b). Therefore, the Department is issuing this amendment as a final rule. Regulatory Flexibility Act/Executive Order 13272: Small Business Because this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act. Nonetheless, consistent with the Regulatory Flexibility Act, the Department certifies that this rule will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by 5 U.S.C. 804. The Department is aware of no monetary effect on the economy that would result from this rulemaking, nor will there be any increase in costs or prices; or any effect on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and import markets. Executive Orders 12866 and 13563 The Department of State has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Orders 12866 and 13563, and has determined that the benefits of this regulation outweigh any cost. The Department does not consider this rule to be a economically significant rulemaking action. Executive Orders 12372 and 13132: Federalism This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The rule will not have federalism implications warranting the application of Executive Orders 12372 and 13132. Executive Order 12988: Civil Justice Reform The Department has reviewed the regulation in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. Executive Order 13175 The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking. Paperwork Reduction Act This rule does not impose or revise information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C. Chapter 35. List of Subjects in 22 CFR Part 35 Administrative practice and procedure, Claims, Fraud, Penalties. For the reasons stated in the preamble, amend part 35 of title 22 of the Code of Federal Regulations as follows: PART 35--PROGRAM FRAUD CIVIL REMEDIES 0 1. The authority citation for part 35 is revised to read as follows: Authority: 22 U.S.C. 2651a; 31 U.S.C. 3801 et seq. 0 2. Revise Sec. 35.2(r) to read as follows: Sec. 35.2 Definitions. * * * * * (r) Reviewing official means the Assistant Legal Adviser for Buildings and Acquisitions or her or his designee who is-- [[Page 49140]] (1) Not subject to supervision by, or required to report to, the investigating official; (2) Not employed in the organizational unit of the authority in which the investigating official is employed; and (3) Serving in a position for which the rate of basic pay is not less than the minimum rate of basic pay for grade GS-16 under the General Schedule. * * * * * Dated: August 3, 2015. Patrick F. Kennedy, Under Secretary of State for Management, Department of State. [FR Doc. 2015-20263 Filed 8-14-15; 8:45 am] BILLING CODE 4710-08-P
![49138 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Rules and Regulations
description of the construct validity of IV. Reference described in detail in the software
the device. The following reference has been requirements specification (SRS) and
Æ A warning that the device does not software design specification (SDS).
placed on display in the Division of
identify the presence or absence of Appropriate software verification,
Dockets Management (HFA–305), Food
clinical diagnoses. validation, and hazard analysis must be
and Drug Administration, 5630 Fishers
Æ A warning that the device is not a performed.
Lane, Rm. 1061, Rockville, MD 20852,
stand-alone diagnostic. (2) The device must be designed and
Æ The intended use population and and may be seen by interested persons
tested for electrical safety.
the intended use environment. between 9 a.m. and 4 p.m., Monday (3) The labeling must include:
Æ Any instructions technicians must through Friday, and is available (i) A summary of any testing
convey to patients regarding the electronically at http:// conducted to demonstrate how the
administration of the test and collection www.regulations.gov. device functions as an interpretation of
of cognitive test data. 1. DEN130033: De Novo Request per 513(f)(2) the current level of cognitive function.
Computerized cognitive assessment of the Federal Food, Drug, and Cosmetic The summary of testing must include
aids are prescription devices restricted Act from Cerebral Assessment Systems, the following, if available: Any expected
to patient use only upon the Inc., dated June 24, 2013. or observed adverse events and
authorization of a practitioner licensed List of Subjects in 21 CFR Part 882 complications; any performance
by law to administer or use the device; measurements including sensitivity,
see 21 CFR 801.109 (Prescription Medical devices, Neurological specificity, positive predictive value
devices). devices. (PPV), and negative predictive value
Section 510(m) of the FD&C Act Therefore, under the Federal Food, (NPV) per the devices intended use; a
provides that FDA may exempt a class Drug, and Cosmetic Act and under description of the repeatability of
II device from the premarket notification authority delegated to the Commissioner measurements; a description of how the
requirements under section 510(k), if of Food and Drugs, 21 CFR part 882 is cut-off values for categorization of
FDA determines that premarket amended as follows: measurements were determined; and a
notification is not necessary to provide description of the construct validity of
reasonable assurance of the safety and PART 882—NEUROLOGICAL DEVICES the device.
effectiveness of the device. For this type (ii) A warning that the device does not
■ 1. The authority citation for 21 CFR
of device, FDA has determined that identify the presence or absence of
part 882 continues to read as follows:
premarket notification is necessary to clinical diagnoses.
provide reasonable assurance of the Authority: 21 U.S.C. 351, 360, 360c, 360e, (iii) A warning that the device is not
safety and effectiveness of the device. 360j, 371. a stand-alone diagnostic.
Therefore, this device type is not ■ 2. Add § 882.1470 to subpart B to read (iv) The intended use population and
exempt from premarket notification as follows: the intended use environment.
requirements. Persons who intend to (v) Any instructions technicians must
market this type of device must submit § 882.1470 Computerized cognitive convey to patients regarding the
assessment aid. administration of the test and collection
to FDA a premarket notification, prior to
marketing the device, which contains (a) Identification. The computerized of cognitive test data.
information about the computerized cognitive assessment aid is a Dated: August 11, 2015.
cognitive assessment aid they intend to prescription device that uses an Leslie Kux,
market. individual’s score(s) on a battery of
Associate Commissioner for Policy.
cognitive tasks to provide an
II. Environmental Impact interpretation of the current level of [FR Doc. 2015–20177 Filed 8–14–15; 8:45 am]
cognitive function. The computerized BILLING CODE 4164–01–P
The Agency has determined under 21
CFR 25.34(b) that this action is of a type cognitive assessment aid is used only as
that does not individually or an assessment aid to determine level of
cumulatively have a significant effect on cognitive functioning for which there DEPARTMENT OF STATE
the human environment. Therefore, exists other valid methods of cognitive
assessment and does not identify the 22 CFR Part 35
neither an environmental assessment
nor an environmental impact statement presence or absence of clinical [Public Notice 9220]
is required. diagnoses. The computerized cognitive RIN 1400–AD85
assessment aid is not intended as a
III. Paperwork Reduction Act of 1995 stand-alone or adjunctive diagnostic Program Fraud Civil Remedies
This final order establishes special device.
controls that refer to previously (b) Classification. Class II (special AGENCY: Department of State.
approved collections of information controls). The special control(s) for this ACTION: Final rule.
found in other FDA regulations. These device are:
collections of information are subject to SUMMARY: The Department of State is
(1) The technical parameters of the
review by the Office of Management and updating its regulations regarding its
device’s hardware and software must be
Budget (OMB) under the Paperwork implementation of the Program Fraud
fully characterized and be accompanied
Reduction Act of 1995 (44 U.S.C. 3501– Civil Remedies Act of 1986, to remove
by appropriate non-clinical testing:
3520). The collections of information in a conflict between the ‘‘reviewing
(i) Hardware specifications must be
part 807, subpart E regarding premarket official’’ and the ‘‘authority head’’ as
provided. Appropriate verification,
tkelley on DSK3SPTVN1PROD with RULES
notification submissions have been defined by the implementing
validation, and hazard analysis must be
approved under OMB control number regulations.
performed.
0910–0120, and the collections of (ii) Software, including any DATES: This rule is effective August 17,
information in 21 CFR part 801, proprietary algorithm(s) used by the 2015.
regarding labeling have been approved device to arrive at its interpretation of FOR FURTHER INFORMATION CONTACT:
under OMB control number 0910–0485. the patient’s cognitive function, must be Alice Kottmyer, Attorney-Adviser,
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![49140 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Rules and Regulations
(1) Not subject to supervision by, or I. Background regulation published by the Department
required to report to, the investigating HUD’s regulations at 24 CFR part 15 of Justice (DOJ) on March 21, 2011 (76
official; contain the policies and procedures FR 15236). DOJ intended that its
(2) Not employed in the governing public access to HUD records regulation serve as a model for all
organizational unit of the authority in under the FOIA (5 U.S.C. 552). Subject agencies in updating their own FOIA
which the investigating official is to certain statutory exceptions, the FOIA regulations.1 As a result of its review,
employed; and gives persons the right to request and HUD published a proposed rule on May
(3) Serving in a position for which the receive a wide range of information 31, 2013 (78 FR 32595), modeled on
rate of basic pay is not less than the from any Federal agency. The FOIA has DOJ’s proposed regulation, to
minimum rate of basic pay for grade been amended several times since its incorporate changes enacted by the
GS–16 under the General Schedule. enactment in 1966. In 2007, significant OPEN Government Act of 2007, reflect
* * * * * amendments to the FOIA were made by developments in case law, include
the Openness Promotes Effectiveness in current cost figures for calculating and
Dated: August 3, 2015. charging fees, and enhance the
Patrick F. Kennedy, our National Government Act of 2007
administration and operation of HUD’s
Under Secretary of State for Management, (OPEN Government Act) (Pub. L. 110–
FOIA program by increasing the
Department of State. 175, approved December 31, 2007). The
transparency and clarity of the
OPEN Government Act made several
[FR Doc. 2015–20263 Filed 8–14–15; 8:45 am] regulation.
amendments to procedural issues
BILLING CODE 4710–08–P
affecting FOIA administration, II. Changes and Clarifications Made in
including the protection of the fee status This Final Rule
for news media, the time limits for This final rule follows publication of
DEPARTMENT OF HOUSING AND agencies to act upon FOIA requests, the the May 31, 2013, proposed rule and
URBAN DEVELOPMENT availability of agency records takes into consideration the public
maintained by a private entity, the comments received on the proposed
24 CFR Part 15 establishment of a FOIA Public Liaison rule. In response to public comment, a
and FOIA Requester Service Center, and discussion of which is presented in the
[Docket No. FR–5624–F–02] the requirement to describe the following section of this preamble, and
exemptions authorizing the redaction of in further consideration of issues
RIN 2501–AD57 material provided under the FOIA. addressed at the proposed rule stage, the
In addition to these statutory changes, Department is making the following
Revision of Freedom of Information several policy directives have been
Act Regulation changes at this final rule:
issued that affect HUD’s FOIA program. • HUD is revising § 15.103(c) to state
AGENCY: Office of the Deputy Secretary, These policy directives include that HUD will provide written notice to
HUD. Presidential memoranda dated January requesters when the time limits for
ACTION: Final rule. 21, 2009, entitled ‘‘Freedom of HUD’s response will be delayed. HUD
Information Act’’ (74 FR 4683, January will also provide the requester with the
SUMMARY: This final rule amends HUD’s 26, 2009), which applies a presumption date by which HUD expects to complete
regulations implementing the Freedom of disclosure in FOIA decision-making its processing of the request.
of Information Act (FOIA) to update and and ‘‘Transparency and Open • HUD is revising § 15.104(c)(3) to
streamline HUD’s current FOIA Government’’ (74 FR 4685, January 26, mirror the language of the FOIA.
regulation. Specifically, it updates 2009), which encourages Federal Specifically, HUD is removing the
HUD’s regulations to reflect statutory agencies to harness new technologies to requirement that a representative of the
changes to the FOIA, current HUD proactively post online information news media, if not a full-time member
organizational structure, and current about their operations and decisions of the news media, should establish that
HUD policies and practices with respect consistent with applicable law. As he or she is a person whose main
to the FOIA. In addition, the rule uses required by the Presidential professional activity or occupation is
current cost figures in calculating and memoranda, on March 19, 2009, information dissemination.
charging fees. This final rule also Attorney General Eric Holder issued • HUD is revising § 15.106(c) to
incorporates changes made upon further comprehensive new FOIA guidelines reduce the duplication costs that HUD
evaluation of HUD’s FOIA Regulation (see http://www.justice.gov/ag/foia- will charge for a paper photocopy of a
and in response to public comments memo-march2009.pdf). The Attorney record from $0.18 per page to $0.10 per
received. General’s guidance further advises that page.
agencies should release information to • HUD is revising § 15.107(a) to refer
DATES: Effective: September 16, 2015. to the most current Executive order
the fullest extent of the law, including
FOR FURTHER INFORMATION CONTACT: information that may be legally regarding classified information, which
Dolores W. Cole, Director, FOIA and withheld, provided there is no is Executive Order 13526, issued
Executive Correspondence, Office of foreseeable harm to an interest protected December 29, 2009.
Administration, Department of Housing by an exemption or the disclosure is not • HUD is removing proposed § 15.109
and Urban Development, 451 7th Street prohibited by law. In addition, the from this final rule. Upon review HUD
SW., Room 10139, Washington, DC Attorney General’s FOIA guidelines has determined that, § 15.109, entitled
20410–0500; telephone number 202– emphasized that agencies must have ‘‘Mortgage sales,’’ directed itself to a
402–2671 (this is not a toll-free effective systems in place for specific HUD program rather than
tkelley on DSK3SPTVN1PROD with RULES
number). Hearing- or speech-impaired responding to FOIA requests. establish disclosure policy applicable
individuals may access this number via Consistent with this law and
TTY by calling the Federal Relay guidance, HUD undertook a 1 See, http://www.justice.gov/sites/default/files/
Service at telephone number 1–800– testimonies/witnesses/attachments/03/15/11/03-15-
comprehensive review of its FOIA 11-oip-pustay-testimony-re-the-freedom-of-
877–8339 (this is a toll-free number). regulation. As part of this review, HUD information-act---ensuring-transparency-and-
SUPPLEMENTARY INFORMATION: looked to the proposed updated FOIA accountability-in-the-digital-age.pdf.
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Document Created: 2015-12-15 11:06:56
Document Modified: 2015-12-15 11:06:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective August 17, 2015. | |
| Contact | Alice Kottmyer, Attorney-Adviser, Office of the Legal Adviser, (202) 647-2318, or [email protected] | |
| FR Citation | 80 FR 49138 | |
| RIN Number | 1400-AD85 | |
| CFR Associated | Administrative Practice and Procedure; Claims; Fraud and Penalties |
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