340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date, 12508-12509 [2017-04337]
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Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Rules and Regulations
(f) Inter-agency or intra-agency
memoranda or letters that would not be
available by law to a party other than an
agency in litigation with the agency.
This exemption shall not apply to
records created 25 years or more before
the date on which the records were
requested.
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■ 5. Amend § 3004.12 by revising
paragraph (c) to read as follows:
§ 3004.12
Reading room.
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(c) The Commission shall make
available, in an electronic and physical
reading room, records previously
released under FOIA and which the
Commission determines are or are likely
to become of significant public interest,
including agency records that have been
requested three or more times.
■ 6. Amend § 3004.13 by revising
paragraph (a) to read as follows:
§ 3004.13 Notice and publication of public
information.
(a) Decisions, advisory opinions,
orders, public reports, and agency
records that have been requested three
or more times will be made available to
the public by posting on the
Commission’s Web site at https://
www.prc.gov.
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■ 7. Amend § 3004.43 by revising
paragraph (a) to read as follows:
§ 3004.43
Response to requests.
asabaliauskas on DSK3SPTVN1PROD with RULES
(a) Within 20 days (excluding
Saturdays, Sundays, and legal holidays)
after receipt of a request for a
Commission record, the Secretary or
Assistant Secretary will notify the
requester of its determination to grant or
deny the request and the right to seek
assistance from the Commission’s FOIA
Public Liaison. In the case of an adverse
determination, the Commission will
notify the requester of their right to
appeal and right to seek dispute
resolution services from the
Commission’s FOIA Public Liaison or
the Office of Government Information
Services.
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■ 8. Amend § 3004.44 by revising
paragraphs (b) and (c)(1) to read as
follows:
§ 3004.44
Appeals.
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(b) A requester who seeks to appeal
any adverse determination must file an
appeal with the Commission within 1
year of the date of the Commission’s
response.
(c)(1) The Commission will grant or
deny the appeal in writing within 20
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18:33 Mar 03, 2017
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days (excluding Saturdays, Sundays,
and legal holidays) of the date the
appeal is received. If on appeal the
adverse determination is upheld, the
Commission will notify the requester of
the availability of dispute resolution
services from the Office of Government
Information Services as a voluntary,
non-exclusive alternative to litigation
and the provisions for judicial review of
that determination pursuant to 5 U.S.C.
552(c).
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■ 9. Revise § 3004.45 to read as follows:
§ 3004.45
Fees—general provisions.
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(e) No requester will be charged a fee
after any search or response which
occurs after the applicable time limits as
described in §§ 3004.43 and 3004.44,
unless:
(1) The Commission extends the time
limit for its response due to unusual
circumstances, pursuant to § 3004.45(a),
and the Commission completes its
response within the extension of time
provided under that section; or
(2) The Commission extends the time
limit for its response due to unusual
circumstances and more than 5,000
pages are necessary to respond to the
request and the Commission has
discussed with the requester how they
could effectively limit the scope of the
request or made at least three good faith
attempts to do so; or
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[FR Doc. 2017–04308 Filed 3–3–17; 8:45 am]
BILLING CODE 7710–FW–P
Extension of response time limit.
(a) The Commission may extend the
time limit for a response to a request or
appeal for up to 10 business days due
to unusual circumstances, as specified
in 5 U.S.C. 552(a)(6)(B)(iii). In such a
case, the Commission will notify the
requester in writing of the unusual
circumstance causing the extension and
the date by which the Commission
estimates that the request can be
processed.
(b) If an extension will exceed 10
business days, the Commission will:
(1) Provide the requester with an
opportunity to limit the scope of the
request or to arrange an alternative
timeframe for processing the request or
a modified request. The applicable time
limits are not tolled while the
Commission waits for a response from
the requester under this subsection; and
(2) Make its FOIA Public Liaison
available to the requester and apprise
the requester of their right to seek
dispute resolution services from the
Office of Government Information
Services.
■ 10. Amend § 3004.52 by revising
paragraph (e) and adding paragraph (f)
to read as follows:
§ 3004.52
(3) A court has determined that
exceptional circumstances exist and
excused the Commission from
responding by court order.
(f) The Commission may, however,
charge fees for review, and in some
cases duplication, for a partial grant of
a request while it reviews records that
may be exempt and may be responsive
to the request, so long as the partial
grant is made within the applicable time
limits.
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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
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Final rule; delay of effective
date.
AGENCY:
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
SUMMARY:
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06MRR1
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Rules and Regulations
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 438
[CMS–2390–F4]
RIN–0938–AS25
Medicaid and Children’s Health
Insurance Program (CHIP) Programs;
Medicaid Managed Care, CHIP
Delivered in Managed Care, and
Revisions Related to Third Party
Liability; Corrections
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correcting
amendment.
AGENCY:
This document corrects
technical errors that appeared in the
correcting amendment published in the
January 3, 2017 Federal Register (82 FR
37 through 40) entitled, ‘‘Medicaid and
Children’s Health Insurance Program
(CHIP) Programs; Medicaid Managed
Care, CHIP Delivered in Managed Care,
and Revisions Related to Third Party
Liability; Corrections.’’
DATES: Effective Date: This correcting
document is effective March 3, 2017.
Applicability Date: The corrections
indicated in this document are
applicable beginning immediately.
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SUMMARY:
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18:33 Mar 03, 2017
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FOR FURTHER INFORMATION CONTACT:
Elmer Barksdale, 410–786–1943, Gaysha
Brooks, 410–409–3837, or Annette
Brewer, 410–786–6580.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2016–31650 (82 FR 37
through 40), the correcting amendment
entitled, ‘‘Medicaid and Children’s
Health Insurance Program (CHIP)
Programs; Medicaid Managed Care,
CHIP Delivered in Managed Care, and
Revisions Related to Third Party
Liability; Corrections’’ there were
technical errors that are identified and
corrected in this correcting document.
These corrections are applicable
immediately.
II. Summary of Errors in Regulation
Text
On page 39, we made technical errors
in the amendatory instructions
amending the regulation text of
§ 438.358(c)(3) and (4). Therefore, the
Office of the Federal Register was not
able to properly correct the regulations
text as intended.
III. Waiver of Proposed Rulemaking
and Delay in Effective Date
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (APA),
the agency is required to publish a
notice of the proposed rule in the
Federal Register before the provisions
of a rule take effect. In addition, section
553(d) of the APA mandates a 30-day
delay in effective date after issuance or
publication of a rule. Sections 553(b)(B)
and 553(d)(3) of the APA provide for
exceptions from the APA requirement
for notice and comment, and delay in
effective date requirements. Section
553(b)(B) of the APA authorizes an
agency to dispense with normal notice
and comment rulemaking procedures
for good cause if the agency makes a
finding that the notice and comment
process is impracticable, unnecessary,
or contrary to the public interest; and
includes a statement of the finding and
the reasons for it in the notice.
In our view, this correcting document
does not constitute a rulemaking that
would be subject to these requirements.
This document merely corrects
technical errors in the Medicaid and
Children’s Health Insurance Program
(CHIP) Programs; Medicaid Managed
Care, CHIP Delivered in Managed Care,
and Revisions Related to Third Party
Liability; Corrections correcting
amendment. The corrections contained
in this document are consistent with,
and do not make substantive changes to,
the policies and payment methodologies
that were adopted subject to notice and
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12509
comment procedures in the Medicaid
and Children’s Health Insurance
Program (CHIP) Programs; Medicaid
Managed Care, CHIP Delivered in
Managed Care, and Revisions Related to
Third Party Liability final rule. As a
result, the corrections made through this
correcting document are intended to
ensure that the Medicaid and Children’s
Health Insurance Program (CHIP)
Programs; Medicaid Managed Care,
CHIP Delivered in Managed Care, and
Revisions Related to Third Party
Liability final rule accurately reflects
the policies adopted in that rule.
Even if this were a rulemaking to
which the notice and comment and
delayed effective date requirements
applied, we find that there is good cause
to waive such requirements.
Undertaking further notice and
comment procedures to incorporate the
corrections in this document into the
Medicaid and Children’s Health
Insurance Program (CHIP) Programs;
Medicaid Managed Care, CHIP
Delivered in Managed Care, and
Revisions Related to Third Party
Liability final rule or delaying the
effective date of the corrections would
be contrary to the public interest
because it could result in a period of
confusion about the applicability of the
rules while those procedures are
pending. Further, such procedures
would be unnecessary, because the
corrections in this document do not
make substantive changes in the
underlying policies but are limited to
technical errors. This correcting
document is intended solely to ensure
that the Medicaid and Children’s Health
Insurance Program (CHIP) Programs;
Medicaid Managed Care, CHIP
Delivered in Managed Care, and
Revisions Related to Third Party
Liability final rule accurately reflects
the final policy determinations that
were set forth in the overall rulemaking
record. For these reasons, we believe
there is good cause to waive the
requirements for notice and comment
and delay in effective date.
List of Subjects in 42 CFR Part 438
Grant programs—health, Medicaid,
Reporting and recordkeeping
requirements.
Correction
In FR Doc. 2016–31650, published on
January 3, 2017 (82 FR 37), make the
following correction:
On page 39, in the third column,
remove amendatory instructions 8 and 9
and their amendments to § 438.358.
Accordingly, 42 CFR chapter IV is
corrected by making the following
correcting amendments to part 438:
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06MRR1
Agencies
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Rules and Regulations]
[Pages 12508-12509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04337]
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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