Information about http://www.oig.hhs.gov/authorities/docs/08/73_fr_15937.pdf
Federal…
Tags: attachments, cilantro, commodity, criminal sanctions, electronic comments, federal register, imposition, leafy greens, leaves, microsoft, proposals, spinach,Pages: 3
Language: english
Created: Wed Mar 26 03:31:30 2008
Display cached document
Page 1
Page 2
Page 3
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations 15937
Parts per 1. Electronically. You may submit section 1128A(b) of the Act 1; and (4)
Commodity million electronic comments on specific whether an activity or proposed activity
recommendations and proposals constitutes grounds for the imposition
* * * * * through the Federal eRulemaking Portal of civil or criminal sanctions under
Cilantro, leaves ..................... 9.0 at http://www.regulations.gov. sections 1128, 1128A, or 1128B of the
* * * * *
Leafy greens, subgroup 4A,
(Attachments should be in Microsoft Act.
except spinach .................. 9.0 Word, if possible.)
2. By regular, express, or overnight B. OIG Final Regulations
Mango ................................... 3.0
* * * * * mail. You may send written comments OIG published an interim final rule
Okra ...................................... 4.0 to the following address: Office of
(62 FR 7350; February 19, 1997)
Papaya .................................. 3.0 Inspector General, Department of Health
* * * * * establishing a new part 1008 in 42 CFR
and Human Services, Attention: OIG
Sapodilla ............................... 3.0 chapter V addressing various procedural
223IFC, Room 5246, Cohen Building,
Sapote, black ........................ 3.0 issues and aspects of the advisory
330 Independence Avenue, SW.,
Sapote, mamey .................... 3.0 opinion process. In response to public
* * * * * Washington, DC 20201. Please allow
comments received on the interim final
Star apple ............................. 3.0 sufficient time for mailed comments to
regulations, we published a final rule
* * * * * be received before the close of the
(63 FR 38311; July 16, 1998) revising
Vegetable, fruiting, group 8, comment period.
except tomato ................... 4.0 3. By hand or courier. If you prefer, and clarifying various aspects of the
you may deliver, by hand or courier, earlier rulemaking. The rulemaking
* * * * * your written comments before the close established procedures for requesting an
period to Office of Inspector General, advisory opinion. Specifically, the rule
[FR Doc. E86205 Filed 32508; 8:45 am] provided information to the public
Department of Health and Human
BILLING CODE 656050S
Services, Cohen Building, 330 regarding costs associated with
Independence Avenue, SW., preparing an opinion and procedures for
Washington, DC 20201. Because access submitting an initial deposit and final
DEPARTMENT OF HEALTH AND to the interior of the Cohen Building is payment to OIG for such costs.
HUMAN SERVICES not readily available to persons without II. Provisions of the Interim Final Rule
Office of the Secretary Federal Government identification,
commenters are encouraged to schedule By statute, the Department must
Office of Inspector General their delivery with one of our staff charge a fee equal to the costs incurred
members at (202) 3583141. by the Department in responding to a
For information on viewing public request for an advisory opinion. (42
42 CFR Part 1008
comments, please see section IV in the U.S.C. 1320a7d(b)(5)(B)(ii)). Under the
Medicare and State Health Care SUPPLEMENTARY INFORMATION section interim final and final advisory opinion
Programs: Fraud and Abuse; Issuance below. rules, we directed requestors to make an
of Advisory Opinions by OIG FOR FURTHER INFORMATION CONTACT: initial payment to the U.S. Treasury by
Meredith Melmed, Office of Counsel to check or money order in the amount of
AGENCY: Office of Inspector General $250. The regulations have also allowed
(OIG), HHS. the Inspector General, (202) 6190335.
SUPPLEMENTARY INFORMATION: for the acceptance of final payment of
ACTION: Interim final rule with comment the fee by check or money order.
period. I. Background
Through this interim final rule, we are
SUMMARY: In accordance with section A. Section 205 of Public Law 104191 setting forth several revisions to the
205 of the Health Insurance Portability The Health Insurance Portability and payment process for advisory opinion
and Accountability Act of 1996, this Accountability Act of 1996 (HIPAA), requests. Specifically, we are modifying
final rule amends the OIG regulations at Public Law 104101, specifically our procedures for submitting an
42 CFR part 1008 by (1) revising the required the Department to provide a advisory opinion request by deleting the
process for advisory opinion requestors formal guidance process to requesting current requirements at §§ 1008.31(b)
to submit payments for advisory individuals and entities regarding the and 1008.36(b)(6) for an initial payment
opinion costs, and (2) clarifying that application of the anti-kickback statute, of $250 for each advisory opinion
notices to the public announcing the safe harbor provisions, and other request, and replacing the existing
procedures for processing advisory OIG health care fraud and abuse provision set forth in § 1008.31(b) with
opinion requests will be published on sanctions. In accordance with section a requirement that payment for an
OIG's Web site. 205 of HIPAA, the Department, in advisory opinion be made directly to the
DATES: Effective Date: These regulations consultation with the Department of Treasury of the United States, as
are effective on April 25, 2008. Justice, issues written advisory opinions directed by OIG. In addition, we are
Comment Period: To assure to parties with regard to: (1) What amending § 1008.43(d) to state that an
consideration, public comments must be constitutes prohibited remuneration advisory opinion will be issued
delivered to the address provided below under the anti-kickback statute; (2) following receipt by OIG of
by no later than 5 p.m. on April 25, whether an arrangement or proposed confirmation that payment in full has
2008. arrangement satisfies the criteria in been remitted by the requesting party to
ADDRESSES: In commenting, please refer section 1128B(b)(3) of the Social the Department of Treasury as directed
to file code OIG223IFC. Because of Security Act (the Act), or established by by OIG.
sroberts on PROD1PC70 with RULES
staff and resource limitations, we cannot regulation, for activities which do not
1 Public Law 104191 erroneously cited this
accept comments by facsimile (FAX) result in prohibited remuneration; (3)
provision as section 1128B(b) of the Act. Section
transmission. what constitutes an inducement to 4331(a) of the Balanced Budget Act of 1997, Public
You may submit comments in one of reduce or limit services to Medicare or Law 10533, corrected this citation to section
three ways (no duplicates, please): Medicaid program beneficiaries under 1128A(b) of the Act.
VerDate Aug2005 16:40 Mar 25, 2008 Jkt 214001 PO 00000 Frm 00077 Fmt 4700 Sfmt 4700 E:\FR\FM\26MRR1.SGM 26MRR1
15938 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
A. Electronic Payment Directly to the which OIG will accept and/or analyze a Law 1044, requires that agencies assess
U.S. Treasury request. OIG expects that this rule will anticipated costs and benefits before
As of the effective date of this rule, we further the public's interest in minimal issuing any rule that may result in
will no longer accept checks or money burden by deleting the requirement for expenditures in any one year by State,
orders from requesting parties and will an initial payment of a deposit to be local or tribal governments, in the
require payments to be made directly to credited toward the final advisory aggregate, or by the private sector, of
the United States Treasury through wire opinion processing costs and by $110 million. Since the rule merely
or other electronic funds transfer. allowing the use of electronic transfers revises the process for paying for
Changing the requirement that payment of funds. The rule will also provide advisory opinions and creates greater
be made by check or money order to greater efficiency in processing efficiencies in processing payments, we
provide for wire or other electronic payments from requestors and will save believe that this rule that will not
funds transfers will create efficiencies in staff time. impose any mandates on State, local, or
processing payments for advisory tribal governments or the private sector
B. Regulatory Analysis
opinion requests, reduce the use of staff that would result in an expenditure of
We have examined the impact of this $110 million or more (adjusted for
resources to process such payments, and
rule as required by Executive Order inflation) in any given year, and that a
reduce the burden on requesting parties.
12866, the Unfunded Mandates Reform full analysis under the Unfunded
B. Elimination of Initial Deposit Act of 1995, the Regulatory Flexibility Mandates Reform Act is not necessary.
We are also eliminating the initial Act (RFA) of 1980, and Executive Order
13132. Regulatory Flexibility Act
deposit payment from the requirements
for submitting an advisory opinion The RFA and the Small Business
Executive Order 12866
request. A deposit is not required by Regulatory Enforcement and Fairness
Executive Order 12866 directs Act of 1996, which amended the RFA,
statute. We believe that deleting the
agencies to assess all costs and benefits require agencies to analyze options for
initial deposit payment will further
of available regulatory alternatives and, regulatory relief of small entities. For
streamline the electronic payment
if regulations are necessary, to select purposes of the RFA, small entities
process and will eliminate
regulatory approaches that maximize include small businesses, certain
administrative burdens that may arise if
net benefits (including potential nonprofit organizations, and small
an initial deposit must be returned. For
economic, environmental, public health, governmental jurisdictions. Individuals
instance, where parties erroneously
and safety effects; distributive impacts; and States are not included in the
submit requests that are wholly outside
and equity). A regulatory impact definition of a small entity. The RFA, as
our authority to issue an advisory
analysis must be prepared for major amended, requires an agency to prepare
opinion, such as requests regarding
rules with economically significant and make available to the public a
issues arising under the physician self-
effects (i.e., $100 million or more in any regulatory flexibility analysis that
referral law (42 U.S.C. 1395nn),
given year). describes the effect of a proposed rule
returning funds submitted directly to This is not a major rule, as defined at
the Department of Treasury would be on small entities when the agency is
5 U.S.C. 804(2), and it is not required to publish a general notice of
cumbersome. In addition, eliminating economically significant since the
the initial deposit requirement will proposed rulemaking for any proposed
overall economic effect of the rule is rule. Because this rule is being issued as
reduce the burden on requesting parties less than $100 million annually. As
by consolidating the parties' payment an interim final rule, on the grounds set
indicated in Section II of this preamble, forth above, a regulatory flexibility
obligations into one final payment. We this rule deals exclusively with the
will provide additional instructions to analysis is not required under the RFA.
procedural issues involved in the
the public on our Web site (http:// payment for advisory opinions issued Executive Order 13132
www.oig.hhs.gov) for paying fees owed by OIG. This rule does not address the Executive Order 13132, Federalism,
for advisory opinions via wire or other substance of the anti-kickback statute or establishes certain requirements that an
electronic funds transfer. other sanction statutes. This rule does agency must meet when it promulgates
III. Regulatory Impact Statement not change any costs associated with a rule that imposes substantial direct
requesting an advisory opinion, but, requirements or costs on State and local
A. Administrative Procedure Act rather, clarifies the procedures for governments, preempts State law, or
OIG has determined that the public submitting statutorily-mandated otherwise has Federalism implications.
notice and comment requirements of the payment for costs incurred preparing an In reviewing this rule under the
Administrative Procedure Act, 5 U.S.C. advisory opinion. We believe that the threshold criteria of Executive Order
553(b), do not apply to this rule because aggregate economic impact of this rule 13132, we have determined that this
the rule is procedural in nature and will be minimal and will have no effect rule would not significantly limit the
does not alter the substantive rights of on the economy or on Federal or State rights, roles, and responsibilities of
the affected parties. Therefore, this rule expenditures. To the extent that there is State or local governments. We have
satisfies the exemption from notice and any economic impact, that impact will determined, therefore, that a full
comment rulemaking in 5 U.S.C. likely result in savings of Federal analysis under Executive Order 13132 is
553(b)(A). OIG nevertheless invites dollars through the improved not necessary.
comments on this rule and will consider efficiencies in the use of staff resources The Office of Management and Budget
all timely submitted comments. for processing advisory opinion requests (OMB) has reviewed this rule in
The advisory opinion process is an and payments related to advisory accordance with Executive Order 12866.
established OIG program. This rule is opinion requests, as well as savings for
C. Paperwork Reduction Act
sroberts on PROD1PC70 with RULES
limited to modifying the processing of parties that request advisory opinions.
payments received for advisory opinion In accordance with section
requests. It does not modify eligibility of Unfunded Mandates Reform Act 3506(c)(2)(A) of the Paperwork
a party to request an advisory opinion, Section 202 of the Unfunded Reduction Act of 1995, we are required
nor does it modify the standards under Mandates Reform Act of 1995, Public to solicit public comments, and receive
VerDate Aug2005 16:40 Mar 25, 2008 Jkt 214001 PO 00000 Frm 00078 Fmt 4700 Sfmt 4700 E:\FR\FM\26MRR1.SGM 26MRR1
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations 15939
final OMB approval, on any information properly paid by the requestor, OIG will includes CAS 401, 402, 405, and 406
collection requirements set forth in issue the advisory opinion and (see 9903.2012(b)). In conjunction with
rulemaking. promptly mail it to the requestor by the revised definition of modified
This rule will not impose any regular first class U.S. mail. coverage, the Board also amended the
information collection burden or affect Dated: January 30, 2008. clause at 9903.2014(c) to include CAS
information currently collected by OIG. 405 and 406. However, the Board did
Daniel R. Levinson,
not change the requirement that foreign
IV. Inspection of Public Comments Inspector General.
concerns comply with only CAS 401
All comments received before the end Approved: February 28, 2008. and 402. As a result, the contract clause
of the comment period are available for Michael O. Leavitt, Secretary. at 9903.2014(c) could not be used for
viewing by the public. All comments [FR Doc. E86164 Filed 32508; 8:45 am] foreign concerns without modification
will be posted on http:// BILLING CODE 415201P by the parties.
www.regulations.gov as soon as possible This final rule provides a clause for
after they have been received. use in contracts with foreign concerns
Comments received timely will also be OFFICE OF MANAGEMENT AND that will not require modification.
available for public inspection as they BUDGET Except that it includes only CAS 401
are received at Office of Inspector and 402, this clause is identical to the
General, Department of Health and Office of Federal Procurement Policy clause currently applicable to contracts
Human Services, Cohen Building, 330 subject to modified coverage. To effect
Independence Avenue, SW., 48 CFR Part 9903 this change, this final rule amends
Washington, DC 20201, Monday 9903.2014, Contract Clauses, to
through Friday of each week from 8:30 Cost Accounting Standards Board; include the new clause at (f), Disclosure
a.m. to 4 p.m. To schedule an Contract Clauses and Consistency of Cost Accounting
appointment to view public comments, AGENCY: Cost Accounting Standards Practices--Foreign Concerns.
phone (202) 6190089. The Board received no public
Board, Office of Federal Procurement
comments in response to the proposed
List of Subjects in 42 CFR Part 1008 Policy, OMB.
rule and has adopted the proposed rule
ACTION: Final rule. as a final rule without change.
Administrative practice and
procedure, Fraud, Grant programs-- SUMMARY: The Cost Accounting B. Paperwork Reduction Act
health, Health facilities, Health Standards (CAS) Board has adopted,
professions, Medicaid, Medicare, The Paperwork Reduction Act, Public
without change, a final rule to add a
Penalties. Law 96511, does not apply to this
clause for inclusion in CAS-covered
rulemaking, because this rule imposes
I Accordingly, 42 CFR chapter V, contracts and subcontracts awarded to
no paperwork burden on offerors,
subchapter B is mended as set forth foreign concerns. The Board is taking
affected contractors and subcontractors,
below: this action to provide a standard clause
or members of the public which requires
for use by Government and contractor
PART 1008--[AMENDED] the approval of OMB under 44 U.S.C.
personnel in applying the CAS
3501, et seq.
I 1. The authority citation for part 1008 requirements to contracts and
continues to read as follows: subcontracts awarded to foreign C. Regulatory Flexibility Act, Unfunded
concerns. Mandates Reform Act, Congressional
Authority: 42 U.S.C. 1320a7d(b) Review Act, and Executive Orders
DATES: Effective Date: April 25, 2008.
I 2. Section 1008.31 is amended by FOR FURTHER INFORMATION CONTACT:
12866 and 13132
revising paragraph (b) to read as follows: Laura Auletta, Manager, Cost The Board certifies that this rule will
Accounting Standards Board, 725 17th not have a significant effect on a
§ 1008.31 OIG fees for the cost of advisory
opinions. Street, NW., Room 9013, Washington, substantial number of small entities
DC 20503 (telephone: 2023953256). within the meaning of the Regulatory
* * * * * Flexibility Act, 5 U.S.C. 601, et seq.,
Reference CAS200701F.
(b) Payment Method. Payment for a because small businesses are exempt
request for an advisory opinion must be SUPPLEMENTARY INFORMATION:
from the application of the Cost
made to the Treasury of the United A. Background Accounting Standards. For purposes of
States, as directed by OIG. the Unfunded Mandates Reform Act of
The CAS Board published a proposed
* * * * * rule on June 14, 2007 (72 FR 32829) to 1995, as well as Executive Orders 12866
I 3. Section 1008.36 is amended by provide a clause for use in contracts and 13132, the final rule will not
removing paragraph (b)(6) and with foreign concerns. Prior to significantly or uniquely affect small
redesignating paragraphs (b)(7) and November 4, 1993, modified CAS governments, does not have federalism
(b)(8) as (b)(6) and (b)(7) respectively. coverage required a contractor to implications, and will not result in
* * * * * comply with only CAS 401 and CAS increased expenditures by State, local,
I 4. Section 1008.43 is amended by 402. Similarly, 9903.2011(b)(4) and tribal governments, or by the
revising paragraph (d) to read as required that foreign concerns comply private sector, of $100 million or more.
follows: with only CAS 401 and 402. Thus, prior In addition, the Board has determined
to November 4, 1993, the contract clause that this rule is not economically
§ 1008.43 Issuance of a formal advisory at 9903.2014(c) was used for both significant under the provisions of
opinion. contracts with modified coverage and Executive Order 12866 or otherwise
sroberts on PROD1PC70 with RULES
* * * * * contracts with foreign concerns. subject to Executive Order 12866
(d) After OIG has notified the However, on November 4, 1993, the review. Finally, the final rule is not a
requestor of the full amount owed and Board revised the definition of modified ``major rule'' under 5 U.S.C. Chapter 8;
OIG has determined that the full coverage to include CAS 405 and 406, the rule will not have any of the effects
payment of that amount has been so that modified coverage currently set forth in 5 U.S.C. 804(2).
VerDate Aug2005 16:40 Mar 25, 2008 Jkt 214001 PO 00000 Frm 00079 Fmt 4700 Sfmt 4700 E:\FR\FM\26MRR1.SGM 26MRR1