82 FR 12508 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 42 (March 6, 2017)
Federal Register Volume 82, Issue 42 (March 6, 2017)
| Page Range | 12508-12509 | |
| FR Document | 2017-04337 |
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)] [Rules and Regulations] [Pages 12508-12509] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04337] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 10 RIN 0906-AA89 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Final rule; delay of effective date. ----------------------------------------------------------------------- SUMMARY: In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,'' published in the January 5, 2017, Federal Register. This document announces that the effective date is delayed until March 21, 2017. DATES: Effective date: This regulation is effective March 3, 2017. The effective date of the final rule published in the January 5, 2017, Federal Register (82 FR 1210), is delayed until March 21, 2017. Compliance date: HHS recognizes that the effective date falls in the middle of a quarter. As such, HHS plans to begin enforcing the requirements of this final rule at the start of the next quarter, which begins April 1, 2017. FOR FURTHER INFORMATION CONTACT: CAPT Krista Pedley, Director, Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353. SUPPLEMENTARY INFORMATION: The January 20, 2017 memorandum from the Assistant to the President and Chief of Staff, titled ``Regulatory Freeze Pending Review,'' published in the Federal [[Page 12509]] Register on January 24, 2017 (82 FR 8346) instructed federal agencies to delay the effective date of rules published in the Federal Register, but which have not yet taken effect, for a period of 60 days from the date of the memorandum. The final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). The effective date of that rule, which would have been March 6, 2017, is now March 21, 2017. The temporary delay in the effective date of this final rule is necessary to give Department officials the opportunity for further review and consideration of new regulations, consistent with the Assistant to the President and Chief of Staff's memorandum. Dated: February 23, 2017. James Macrae, Acting Administrator, Health Resources and Services Administration. Approved: March 1, 2017. Thomas E. Price, Secretary, Department of Health and Human Services. [FR Doc. 2017-04337 Filed 3-2-17; 11:15 am] BILLING CODE 4160-15-P
![12508 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Rules and Regulations
(f) Inter-agency or intra-agency days (excluding Saturdays, Sundays, (3) A court has determined that
memoranda or letters that would not be and legal holidays) of the date the exceptional circumstances exist and
available by law to a party other than an appeal is received. If on appeal the excused the Commission from
agency in litigation with the agency. adverse determination is upheld, the responding by court order.
This exemption shall not apply to Commission will notify the requester of (f) The Commission may, however,
records created 25 years or more before the availability of dispute resolution charge fees for review, and in some
the date on which the records were services from the Office of Government cases duplication, for a partial grant of
requested. Information Services as a voluntary, a request while it reviews records that
* * * * * non-exclusive alternative to litigation may be exempt and may be responsive
■ 5. Amend § 3004.12 by revising and the provisions for judicial review of to the request, so long as the partial
paragraph (c) to read as follows: that determination pursuant to 5 U.S.C. grant is made within the applicable time
552(c). limits.
§ 3004.12 Reading room. * * * * * [FR Doc. 2017–04308 Filed 3–3–17; 8:45 am]
* * * * * ■ 9. Revise § 3004.45 to read as follows: BILLING CODE 7710–FW–P
(c) The Commission shall make
available, in an electronic and physical § 3004.45 Extension of response time limit.
reading room, records previously (a) The Commission may extend the DEPARTMENT OF HEALTH AND
released under FOIA and which the time limit for a response to a request or HUMAN SERVICES
Commission determines are or are likely appeal for up to 10 business days due
to become of significant public interest, to unusual circumstances, as specified 42 CFR Part 10
including agency records that have been in 5 U.S.C. 552(a)(6)(B)(iii). In such a
requested three or more times. case, the Commission will notify the RIN 0906–AA89
■ 6. Amend § 3004.13 by revising requester in writing of the unusual
340B Drug Pricing Program Ceiling
paragraph (a) to read as follows: circumstance causing the extension and
the date by which the Commission Price and Manufacturer Civil Monetary
§ 3004.13 Notice and publication of public estimates that the request can be Penalties; Delay of Effective Date
information. processed. AGENCY: Health Resources and Services
(a) Decisions, advisory opinions, (b) If an extension will exceed 10 Administration (HRSA), HHS.
orders, public reports, and agency business days, the Commission will: ACTION: Final rule; delay of effective
records that have been requested three (1) Provide the requester with an
or more times will be made available to date.
opportunity to limit the scope of the
the public by posting on the request or to arrange an alternative SUMMARY: In accordance with the
Commission’s Web site at http:// timeframe for processing the request or memorandum of January 20, 2017, from
www.prc.gov. a modified request. The applicable time the Assistant to the President and Chief
* * * * * limits are not tolled while the of Staff, entitled ‘‘Regulatory Freeze
■ 7. Amend § 3004.43 by revising Commission waits for a response from Pending Review,’’ this action
paragraph (a) to read as follows: the requester under this subsection; and temporarily delays for 60 days from the
(2) Make its FOIA Public Liaison date of the memorandum the effective
§ 3004.43 Response to requests. available to the requester and apprise date of the final rule titled ‘‘340B Drug
(a) Within 20 days (excluding the requester of their right to seek Pricing Program Ceiling Price and
Saturdays, Sundays, and legal holidays) dispute resolution services from the Manufacturer Civil Monetary Penalties
after receipt of a request for a Office of Government Information Regulation,’’ published in the January 5,
Commission record, the Secretary or Services. 2017, Federal Register. This document
Assistant Secretary will notify the ■ 10. Amend § 3004.52 by revising announces that the effective date is
requester of its determination to grant or paragraph (e) and adding paragraph (f) delayed until March 21, 2017.
deny the request and the right to seek to read as follows: DATES: Effective date: This regulation is
assistance from the Commission’s FOIA
§ 3004.52 Fees—general provisions. effective March 3, 2017. The effective
Public Liaison. In the case of an adverse
date of the final rule published in the
determination, the Commission will * * * * *
January 5, 2017, Federal Register (82 FR
notify the requester of their right to (e) No requester will be charged a fee
1210), is delayed until March 21, 2017.
appeal and right to seek dispute after any search or response which
resolution services from the Compliance date: HHS recognizes that
occurs after the applicable time limits as
Commission’s FOIA Public Liaison or the effective date falls in the middle of
described in §§ 3004.43 and 3004.44,
the Office of Government Information a quarter. As such, HHS plans to begin
unless:
Services. (1) The Commission extends the time enforcing the requirements of this final
limit for its response due to unusual rule at the start of the next quarter,
* * * * * which begins April 1, 2017.
■ 8. Amend § 3004.44 by revising circumstances, pursuant to § 3004.45(a),
and the Commission completes its FOR FURTHER INFORMATION CONTACT:
paragraphs (b) and (c)(1) to read as CAPT Krista Pedley, Director, Office of
follows: response within the extension of time
provided under that section; or Pharmacy Affairs (OPA), Healthcare
§ 3004.44 Appeals. (2) The Commission extends the time Systems Bureau (HSB), HRSA, 5600
asabaliauskas on DSK3SPTVN1PROD with RULES
* * * * * limit for its response due to unusual Fishers Lane, Mail Stop 08W05A,
(b) A requester who seeks to appeal circumstances and more than 5,000 Rockville, MD 20857, or by telephone at
any adverse determination must file an pages are necessary to respond to the 301–594–4353.
appeal with the Commission within 1 request and the Commission has SUPPLEMENTARY INFORMATION: The
year of the date of the Commission’s discussed with the requester how they January 20, 2017 memorandum from the
response. could effectively limit the scope of the Assistant to the President and Chief of
(c)(1) The Commission will grant or request or made at least three good faith Staff, titled ‘‘Regulatory Freeze Pending
deny the appeal in writing within 20 attempts to do so; or Review,’’ published in the Federal
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![Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Rules and Regulations 12509
Register on January 24, 2017 (82 FR FOR FURTHER INFORMATION CONTACT: comment procedures in the Medicaid
8346) instructed federal agencies to Elmer Barksdale, 410–786–1943, Gaysha and Children’s Health Insurance
delay the effective date of rules Brooks, 410–409–3837, or Annette Program (CHIP) Programs; Medicaid
published in the Federal Register, but Brewer, 410–786–6580. Managed Care, CHIP Delivered in
which have not yet taken effect, for a SUPPLEMENTARY INFORMATION: Managed Care, and Revisions Related to
period of 60 days from the date of the Third Party Liability final rule. As a
memorandum. The final rule sets forth I. Background result, the corrections made through this
the calculation of the 340B ceiling price In FR Doc. 2016–31650 (82 FR 37 correcting document are intended to
and application of civil monetary through 40), the correcting amendment ensure that the Medicaid and Children’s
penalties (CMPs). The effective date of entitled, ‘‘Medicaid and Children’s Health Insurance Program (CHIP)
that rule, which would have been March Health Insurance Program (CHIP) Programs; Medicaid Managed Care,
6, 2017, is now March 21, 2017. The Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and
temporary delay in the effective date of CHIP Delivered in Managed Care, and Revisions Related to Third Party
this final rule is necessary to give Revisions Related to Third Party Liability final rule accurately reflects
Department officials the opportunity for Liability; Corrections’’ there were the policies adopted in that rule.
further review and consideration of new technical errors that are identified and Even if this were a rulemaking to
regulations, consistent with the corrected in this correcting document. which the notice and comment and
Assistant to the President and Chief of These corrections are applicable delayed effective date requirements
Staff’s memorandum. immediately. applied, we find that there is good cause
to waive such requirements.
Dated: February 23, 2017. II. Summary of Errors in Regulation
Undertaking further notice and
James Macrae, Text
comment procedures to incorporate the
Acting Administrator, Health Resources and On page 39, we made technical errors corrections in this document into the
Services Administration. in the amendatory instructions Medicaid and Children’s Health
Approved: March 1, 2017. amending the regulation text of Insurance Program (CHIP) Programs;
Thomas E. Price, § 438.358(c)(3) and (4). Therefore, the Medicaid Managed Care, CHIP
Secretary, Department of Health and Human Office of the Federal Register was not Delivered in Managed Care, and
Services. able to properly correct the regulations Revisions Related to Third Party
[FR Doc. 2017–04337 Filed 3–2–17; 11:15 am] text as intended. Liability final rule or delaying the
BILLING CODE 4160–15–P
III. Waiver of Proposed Rulemaking effective date of the corrections would
and Delay in Effective Date be contrary to the public interest
because it could result in a period of
DEPARTMENT OF HEALTH AND Under 5 U.S.C. 553(b) of the
confusion about the applicability of the
HUMAN SERVICES Administrative Procedure Act (APA),
rules while those procedures are
the agency is required to publish a
pending. Further, such procedures
Centers for Medicare & Medicaid notice of the proposed rule in the
would be unnecessary, because the
Services Federal Register before the provisions
corrections in this document do not
of a rule take effect. In addition, section
make substantive changes in the
42 CFR Part 438 553(d) of the APA mandates a 30-day
underlying policies but are limited to
delay in effective date after issuance or
[CMS–2390–F4] technical errors. This correcting
publication of a rule. Sections 553(b)(B)
RIN–0938–AS25 document is intended solely to ensure
and 553(d)(3) of the APA provide for
that the Medicaid and Children’s Health
exceptions from the APA requirement
Medicaid and Children’s Health Insurance Program (CHIP) Programs;
for notice and comment, and delay in
Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP
effective date requirements. Section
Medicaid Managed Care, CHIP Delivered in Managed Care, and
553(b)(B) of the APA authorizes an
Delivered in Managed Care, and Revisions Related to Third Party
agency to dispense with normal notice
Revisions Related to Third Party Liability final rule accurately reflects
and comment rulemaking procedures
Liability; Corrections the final policy determinations that
for good cause if the agency makes a
were set forth in the overall rulemaking
AGENCY: Centers for Medicare & finding that the notice and comment
record. For these reasons, we believe
Medicaid Services (CMS), HHS. process is impracticable, unnecessary,
there is good cause to waive the
ACTION: Final rule; correcting or contrary to the public interest; and
requirements for notice and comment
amendment. includes a statement of the finding and
and delay in effective date.
the reasons for it in the notice.
SUMMARY: This document corrects In our view, this correcting document List of Subjects in 42 CFR Part 438
technical errors that appeared in the does not constitute a rulemaking that Grant programs—health, Medicaid,
correcting amendment published in the would be subject to these requirements. Reporting and recordkeeping
January 3, 2017 Federal Register (82 FR This document merely corrects requirements.
37 through 40) entitled, ‘‘Medicaid and technical errors in the Medicaid and
Children’s Health Insurance Program Children’s Health Insurance Program Correction
(CHIP) Programs; Medicaid Managed (CHIP) Programs; Medicaid Managed In FR Doc. 2016–31650, published on
asabaliauskas on DSK3SPTVN1PROD with RULES
Care, CHIP Delivered in Managed Care, Care, CHIP Delivered in Managed Care, January 3, 2017 (82 FR 37), make the
and Revisions Related to Third Party and Revisions Related to Third Party following correction:
Liability; Corrections.’’ Liability; Corrections correcting On page 39, in the third column,
DATES: Effective Date: This correcting amendment. The corrections contained remove amendatory instructions 8 and 9
document is effective March 3, 2017. in this document are consistent with, and their amendments to § 438.358.
Applicability Date: The corrections and do not make substantive changes to, Accordingly, 42 CFR chapter IV is
indicated in this document are the policies and payment methodologies corrected by making the following
applicable beginning immediately. that were adopted subject to notice and correcting amendments to part 438:
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Document Created: 2017-03-04 00:06:54
Document Modified: 2017-03-04 00:06:54
| 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; delay of effective date. | |
| Dates | Effective date: This regulation is effective March 3, 2017. The effective date of the final rule published in the January 5, 2017, Federal Register (82 FR 1210), is delayed until March 21, 2017. Compliance date: HHS recognizes that the effective date falls in the middle of a quarter. As such, HHS plans to begin enforcing the requirements of this final rule at the start of the next quarter, which begins April 1, 2017. | |
| Contact | CAPT Krista Pedley, Director, Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353. | |
| FR Citation | 82 FR 12508 | |
| RIN Number | 0906-AA89 |
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