83 FR 55135 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 213 (November 2, 2018)
Federal Register Volume 83, Issue 213 (November 2, 2018)
| Page Range | 55135-55137 | |
| FR Document | 2018-24057 |
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)] [Proposed Rules] [Pages 55135-55137] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24057] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 10 RIN 0906-AB19 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of proposed rulemaking; effective date change. ----------------------------------------------------------------------- SUMMARY: The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS or Department) proposes to cease any further delay of the rule and change the effective date from July 1, 2019, to January 1, 2019. DATES: Submit comments on or before November 23, 2018 ADDRESSES: You may submit comments, identified by the Regulatory Information Number (RIN) 0906-AB19, by any of the following methods. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions. The first is the preferred method.Federal eRulemaking Portal: http://www.regulations.gov. Follow instructions for submitting comments. This is the preferred method for the submission of comments. Email: 340BCMPNPRM@hrsa.gov. Include 0906-AB19 in the subject line of the message. Mail: Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857. All submitted comments will be available to the public in their entirety. Please do not submit commercial confidential information or personal identifying information that you do not want in the public domain. FOR FURTHER INFORMATION CONTACT: CAPT Krista Pedley, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353. SUPPLEMENTARY INFORMATION: I. Background HHS published a notice of proposed rulemaking (NPRM) in June 2015 to implement civil monetary penalties (CMPs) for manufacturers who knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug; to provide clarity regarding the requirement that manufacturers calculate the 340B ceiling price on a quarterly basis and how the ceiling price is to be calculated; and to establish the requirement that a manufacturer charge a $.01 (penny pricing policy) for drugs when the ceiling price calculation equals zero (80 FR 34583, (June 17, 2015)). The public comment period closed on August 17, 2015, and HRSA received 35 comments. After review of the initial comments, HHS reopened the comment period (81 FR 22960, (April 19, 2016)) to invite additional comments on the following areas of the NPRM: 340B ceiling price calculations that result in a ceiling price that equals zero (penny pricing); the methodology that manufacturers use when estimating the ceiling price for a new covered outpatient drug; and the definition of the ``knowing and intentional'' standard to be applied when assessing a CMP for manufacturers that overcharge a covered entity. The comment period closed May 19, 2016, and HHS received 72 comments. On January 5, 2017, HHS published a final rule in the Federal Register (82 FR 1210, (January 5, 2017)). Comments from both the NPRM and the reopening notice were considered in the development of the final rule. The provisions of that rule were to be effective March 6, 2017; however, through a series of rules, HHS delayed the effective date of the January 5, 2017 final rule until July 1, 2019 (83 FR 25943, June 5, 2018). II. Proposal To Change the Effective Date of the Final Rule From July 1, 2019, to January 1, 2019 HHS proposes to cease any further delay of the January 5, 2017 final rule and to change the effective date from July 1, 2019, to January 1, 2019. As the effective date will be the first day of the quarter, the implementation date and the effective date will be the same. In its most recent rulemaking delaying the effective date of the January 5, 2017 final rule, HHS stated that it ``is developing new comprehensive policies to address the rising costs of prescription drugs. These policies will address drug pricing in government programs, such as Medicare Parts B & D, Medicaid, and the 340B Program. Due to the development of these comprehensive policies, we are delaying the effective date for the January 5, 2017, final rule to July 1, 2019.'' (83 FR 25944) The Department has determined that the finalization of the 340B ceiling price and civil monetary penalty rule will not interfere with the Department's development of these comprehensive policies. Accordingly, the Department no longer believes a delay in the effective date is necessary and is proposing to change the effective date of the rule from July 1, 2019, to January 1, 2019. The provisions included in the January 5, 2017 final rule were subject to extensive public comment, and have been delayed several times. As such, HHS believes that it has considered the full range of comments on the substantive issues in the January 5, 2017 final rule. HHS believes that finalization of this proposed change to the effective date of the January 5, 2017 final rule would satisfy its obligation to implement the statutory provisions enacted by Congress in 2010 to create civil monetary penalties. HHS seeks public comments specifically regarding the impact of ceasing any further delay of the January 5, 2017 final rule, including any potential disruptions to implementation, and changing the effective date from July 1, 2019, to January 1, 2019. HHS encourages all stakeholders to provide comment on this proposed rule. A comment period of 21 days is sufficient to provide affected parties the opportunity to provide their views as this rule is uncomplicated and simply [[Page 55136]] proposes to change an effective date. Moreover, affected parties have had multiple opportunities to provide comments on the appropriate effective date of the January 5, 2017 final. III. Regulatory Impact Analysis HHS has examined the effects of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 8, 2011), the Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999). Executive Orders 12866, 13563, and 13771 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a ``significant regulatory action'' as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities (also referred to as ``economically significant''); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a ``significant'' regulatory action is subject to review by the Office of Management and Budget (OMB). HHS does not believe that the proposal to change the effective date of the January 5, 2017 final rule from July 1, 2019, to January 1, 2019, will have an economic impact of $100 million or more in any 1 year, and is therefore not designated as an ``economically significant'' proposed rule under section 3(f)(1) of Executive Order 12866. The 340B Program as a whole creates significant savings for entities purchasing drugs through the program, with total purchases estimated to be $19 billion in CY 2017. This proposed rule to implement the January 5, 2017 proposed rule would codify current policy, some of which have been modified regarding calculation of the 340B ceiling price and manufacturer civil monetary penalties. HHS does not anticipate that the imposition of civil monetary penalties would result in significant economic impact. When the 2017 Rule was finalized, it was described as not economically significant. Therefore, changing the effective date of the 2017 Rule is also not likely to have an economically significant impact. Specifically, the RIA for the 2017 Rule stated that, ``[. . .] manufacturers are required to ensure they do not overcharge covered entities, and a civil monetary penalty could result from overcharging if it met the standards in this final rule. HHS envisions using these penalties in rare situations. Since the Program's inception, issues related to overcharges have been resolved between a manufacturer and a covered entity and any issues have generally been due to technical errors in the calculation. For the penalties to be used as defined in the statute and in this [2017] rule, the manufacturer overcharge would have to be the result of a knowing and intentional act. Based on anecdotal information received from covered entities, HHS anticipates that this would occur very rarely if at all.'' Since the civil penalties envisioned in the 2017 Rule were expected to be rare, changing the effective date of these civil penalties is unlikely to have an economically significant impact. Executive Order 13771 (January 30, 2017) requires that the costs associated with significant new regulations ``to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.'' This rule is not subject to the requirements of Executive Order 13771 because this rule results in no more than de minimis costs. HHS is seeking specific comments on the potential financial and other impact on covered entities and manufacturers if the final rule were effective on January 1, 2019. The Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. HHS will use an RFA threshold of at least a three percent impact on at least five percent of small entities. The proposed rule would affect drug manufacturers (North American Industry Classification System code 325412: Pharmaceutical Preparation Manufacturing). The small business size standard for drug manufacturers is 750 employees. Approximately 600 drug manufacturers participate in the Program. While it is possible to estimate the impact of the proposed rule on the industry as a whole, the data necessary to project changes for specific manufacturers or groups of manufacturers were not available, as HRSA does not collect the information necessary to assess the size of an individual manufacturer that participates in the 340B Program. For purposes of the RFA, HHS considers all health care providers to be small entities either by virtue of meeting the Small Business Administration (SBA) size standard for a small business, or for being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $7 million to $35.5 million. As of January 1, 2017, over 12,000 covered entities participate in the 340B Program, which represent safety-net healthcare providers across the country. HHS has determined, and the Secretary certifies that this proposed rule will not have a significant impact on the operations of a substantial number of small manufacturers; therefore, we are not preparing an analysis of impact for the purposes of this RFA. HHS estimates that the economic impact on small entities and small manufacturers will be minimal and less than 3 percent. HHS welcomes comments concerning the impact of this proposed rule on small manufacturers and small health care providers. HHS also seeks comments on any impacts of affected parties to reduce by [[Page 55137]] six months, the effective date of the 2017 final rule from July 1, 2019 to January 1, 2019. Unfunded Mandates Reform Act 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 million or more (adjusted annually for inflation) in any one year.'' In 2018, that threshold is approximately $150 million. HHS does not expect this rule to exceed the threshold. Executive Order 13132--Federalism HHS has reviewed this proposed rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have ``federalism implications.'' This rule would not ``have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' The proposal to rescind the June 5, 2018 final rule and make the January 5, 2017 final rule effective as of January 1, 2019 would not adversely affect the following family elements: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under Section 654(c) of the Treasury and General Government Appropriations Act of 1999. HHS invites additional comments on the impact of this proposed rule from affected stakeholders. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that OMB approve all collections of information by a Federal agency from the public before they can be implemented. This proposed rule is projected to have no impact on current reporting and recordkeeping burden for manufacturers under the 340B Program. Changes proposed in this rule would result in no new reporting burdens. Comments are welcome on the accuracy of this statement. List of Subjects in 42 CFR Part 10 Biologics, Business and industry, Diseases, Drugs, Health, Health care, Health facilities, Hospitals. Dated: October 26, 2018. George Sigounas, Administrator, Health Resources and Services Administration. Approved: October 30, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2018-24057 Filed 10-31-18; 11:15 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Proposed Rules 55135
as an assistive listening device, if This is the preferred method for the through a series of rules, HHS delayed
requested 10 calendar days before the submission of comments. the effective date of the January 5, 2017
meeting. The meetings will be open to • Email: 340BCMPNPRM@hrsa.gov. final rule until July 1, 2019 (83 FR
all persons on a space-available basis. Include 0906–AB19 in the subject line 25943, June 5, 2018).
There will be no admission fee or other of the message.
II. Proposal To Change the Effective
charge to attend and participate. • Mail: Office of Pharmacy Affairs
Date of the Final Rule From July 1,
Issued in Washington, DC, on October 30,
(OPA), Healthcare Systems Bureau
2019, to January 1, 2019
2018. (HSB), Health Resources and Services
Administration (HRSA), 5600 Fishers HHS proposes to cease any further
Brandon Roberts,
Lane, Mail Stop 08W05A, Rockville, MD delay of the January 5, 2017 final rule
Deputy Executive Director, Office of and to change the effective date from
Rulemaking.
20857.
All submitted comments will be July 1, 2019, to January 1, 2019. As the
[FR Doc. 2018–24129 Filed 11–1–18; 8:45 am] effective date will be the first day of the
available to the public in their entirety.
BILLING CODE 4910–13–P
Please do not submit commercial quarter, the implementation date and
confidential information or personal the effective date will be the same. In its
identifying information that you do not most recent rulemaking delaying the
DEPARTMENT OF HEALTH AND effective date of the January 5, 2017
want in the public domain.
HUMAN SERVICES final rule, HHS stated that it ‘‘is
FOR FURTHER INFORMATION CONTACT:
developing new comprehensive policies
42 CFR Part 10 CAPT Krista Pedley, Director, OPA, to address the rising costs of
HSB, HRSA, 5600 Fishers Lane, Mail prescription drugs. These policies will
RIN 0906–AB19 Stop 08W05A, Rockville, MD 20857, or address drug pricing in government
340B Drug Pricing Program Ceiling by telephone at 301–594–4353. programs, such as Medicare Parts B & D,
Price and Manufacturer Civil Monetary SUPPLEMENTARY INFORMATION: Medicaid, and the 340B Program. Due to
Penalties Regulation I. Background the development of these
comprehensive policies, we are delaying
AGENCY: Health Resources and Services HHS published a notice of proposed the effective date for the January 5,
Administration, HHS. rulemaking (NPRM) in June 2015 to 2017, final rule to July 1, 2019.’’ (83 FR
ACTION: Notice of proposed rulemaking; implement civil monetary penalties 25944)
effective date change. (CMPs) for manufacturers who The Department has determined that
knowingly and intentionally charge a the finalization of the 340B ceiling price
SUMMARY: The Health Resources and covered entity more than the ceiling and civil monetary penalty rule will not
Services Administration (HRSA) price for a covered outpatient drug; to interfere with the Department’s
administers section 340B of the Public provide clarity regarding the development of these comprehensive
Health Service Act (PHSA), which is requirement that manufacturers policies. Accordingly, the Department
referred to as the ‘‘340B Drug Pricing calculate the 340B ceiling price on a no longer believes a delay in the
Program’’ or the ‘‘340B Program.’’ HRSA quarterly basis and how the ceiling effective date is necessary and is
published a final rule on January 5, price is to be calculated; and to establish proposing to change the effective date of
2017, that set forth the calculation of the the requirement that a manufacturer the rule from July 1, 2019, to January 1,
340B ceiling price and application of charge a $.01 (penny pricing policy) for 2019.
civil monetary penalties. drugs when the ceiling price calculation The provisions included in the
On June 5, 2018, HRSA published a equals zero (80 FR 34583, (June 17, January 5, 2017 final rule were subject
final rule that delayed the effective date 2015)). The public comment period to extensive public comment, and have
of the 340B ceiling price and civil closed on August 17, 2015, and HRSA been delayed several times. As such,
monetary rule until July 1, 2019, to received 35 comments. After review of HHS believes that it has considered the
allow a more deliberate process of the initial comments, HHS reopened the full range of comments on the
considering alternative and comment period (81 FR 22960, (April substantive issues in the January 5, 2017
supplemental regulatory provisions and 19, 2016)) to invite additional comments final rule.
to allow for sufficient time for on the following areas of the NPRM: HHS believes that finalization of this
additional rulemaking. After further 340B ceiling price calculations that proposed change to the effective date of
consideration of the issue, the result in a ceiling price that equals zero the January 5, 2017 final rule would
Department of Health and Human (penny pricing); the methodology that satisfy its obligation to implement the
Services (HHS or Department) proposes manufacturers use when estimating the statutory provisions enacted by
to cease any further delay of the rule ceiling price for a new covered Congress in 2010 to create civil
and change the effective date from July outpatient drug; and the definition of monetary penalties.
1, 2019, to January 1, 2019. the ‘‘knowing and intentional’’ standard HHS seeks public comments
DATES: Submit comments on or before to be applied when assessing a CMP for specifically regarding the impact of
November 23, 2018 manufacturers that overcharge a covered ceasing any further delay of the January
ADDRESSES: You may submit comments, entity. The comment period closed May 5, 2017 final rule, including any
identified by the Regulatory Information 19, 2016, and HHS received 72 potential disruptions to
Number (RIN) 0906–AB19, by any of the comments. implementation, and changing the
following methods. Please submit your On January 5, 2017, HHS published a effective date from July 1, 2019, to
comments in only one of these ways to final rule in the Federal Register (82 FR January 1, 2019.
minimize the receipt of duplicate 1210, (January 5, 2017)). Comments HHS encourages all stakeholders to
submissions. The first is the preferred from both the NPRM and the reopening provide comment on this proposed rule.
method. notice were considered in the A comment period of 21 days is
• Federal eRulemaking Portal: http:// development of the final rule. The sufficient to provide affected parties the
www.regulations.gov. Follow provisions of that rule were to be opportunity to provide their views as
instructions for submitting comments. effective March 6, 2017; however, this rule is uncomplicated and simply
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proposes to change an effective date. to review by the Office of Management on covered entities and manufacturers if
Moreover, affected parties have had and Budget (OMB). the final rule were effective on January
multiple opportunities to provide HHS does not believe that the 1, 2019.
comments on the appropriate effective proposal to change the effective date of
the January 5, 2017 final rule from July The Regulatory Flexibility Act (RFA)
date of the January 5, 2017 final.
1, 2019, to January 1, 2019, will have an The Regulatory Flexibility Act (5
III. Regulatory Impact Analysis economic impact of $100 million or U.S.C. 601 et seq.) (RFA) and the Small
HHS has examined the effects of this more in any 1 year, and is therefore not Business Regulatory Enforcement and
proposed rule as required by Executive designated as an ‘‘economically Fairness Act of 1996, which amended
Order 12866 on Regulatory Planning significant’’ proposed rule under section the RFA, require HHS to analyze
and Review (September 30, 1993), 3(f)(1) of Executive Order 12866. The options for regulatory relief of small
Executive Order 13563 on Improving 340B Program as a whole creates businesses. If a rule has a significant
Regulation and Regulatory Review significant savings for entities economic effect on a substantial number
(January 8, 2011), the Regulatory purchasing drugs through the program, of small entities, the Secretary must
Flexibility Act (September 19, 1980, with total purchases estimated to be $19 specifically consider the economic
Pub. L. 96–354), the Unfunded billion in CY 2017. This proposed rule effect of the rule on small entities and
Mandates Reform Act of 1995 (Pub. L. to implement the January 5, 2017 analyze regulatory options that could
104–4), and Executive Order 13132 on proposed rule would codify current lessen the impact of the rule. HHS will
Federalism (August 4, 1999). policy, some of which have been use an RFA threshold of at least a three
modified regarding calculation of the percent impact on at least five percent
Executive Orders 12866, 13563, and 340B ceiling price and manufacturer of small entities.
13771 civil monetary penalties. HHS does not The proposed rule would affect drug
anticipate that the imposition of civil manufacturers (North American
Executive Orders 12866 and 13563
monetary penalties would result in Industry Classification System code
direct agencies to assess all costs and 325412: Pharmaceutical Preparation
benefits of available regulatory significant economic impact.
When the 2017 Rule was finalized, it Manufacturing). The small business size
alternatives and, if regulation is standard for drug manufacturers is 750
was described as not economically
necessary, to select regulatory employees. Approximately 600 drug
significant. Therefore, changing the
approaches that maximize net benefits manufacturers participate in the
effective date of the 2017 Rule is also
(including potential economic, Program. While it is possible to estimate
not likely to have an economically
environmental, public health and safety the impact of the proposed rule on the
significant impact.
effects, distributive impacts, and Specifically, the RIA for the 2017 Rule industry as a whole, the data necessary
equity). Executive Order 13563 is stated that, ‘‘[. . .] manufacturers are to project changes for specific
supplemental to and reaffirms the required to ensure they do not manufacturers or groups of
principles, structures, and definitions overcharge covered entities, and a civil manufacturers were not available, as
governing regulatory review as monetary penalty could result from HRSA does not collect the information
established in Executive Order 12866, overcharging if it met the standards in necessary to assess the size of an
emphasizing the importance of this final rule. HHS envisions using individual manufacturer that
quantifying both costs and benefits, of these penalties in rare situations. Since participates in the 340B Program. For
reducing costs, of harmonizing rules, the Program’s inception, issues related purposes of the RFA, HHS considers all
and of promoting flexibility. to overcharges have been resolved health care providers to be small entities
Section 3(f) of Executive Order 12866 between a manufacturer and a covered either by virtue of meeting the Small
defines a ‘‘significant regulatory action’’ entity and any issues have generally Business Administration (SBA) size
as an action that is likely to result in a been due to technical errors in the standard for a small business, or for
rule: (1) Having an annual effect on the calculation. For the penalties to be used being a nonprofit organization that is
economy of $100 million or more in any as defined in the statute and in this not dominant in its market. The current
1 year, or adversely and materially [2017] rule, the manufacturer SBA size standard for health care
affecting a sector of the economy, overcharge would have to be the result providers ranges from annual receipts of
productivity, competition, jobs, the of a knowing and intentional act. Based $7 million to $35.5 million. As of
environment, public health or safety, or on anecdotal information received from January 1, 2017, over 12,000 covered
state, local, or tribal governments or covered entities, HHS anticipates that entities participate in the 340B Program,
communities (also referred to as this would occur very rarely if at all.’’ which represent safety-net healthcare
‘‘economically significant’’); (2) creating Since the civil penalties envisioned in providers across the country. HHS has
a serious inconsistency or otherwise the 2017 Rule were expected to be rare, determined, and the Secretary certifies
interfering with an action taken or changing the effective date of these civil that this proposed rule will not have a
planned by another agency; (3) penalties is unlikely to have an significant impact on the operations of
materially altering the budgetary economically significant impact. a substantial number of small
impacts of entitlement grants, user fees, Executive Order 13771 (January 30, manufacturers; therefore, we are not
or loan programs or the rights and 2017) requires that the costs associated preparing an analysis of impact for the
obligations of recipients thereof; or (4) with significant new regulations ‘‘to the purposes of this RFA. HHS estimates
raising novel legal or policy issues extent permitted by law, be offset by the that the economic impact on small
arising out of legal mandates, the elimination of existing costs associated entities and small manufacturers will be
President’s priorities, or the principles with at least two prior regulations.’’ minimal and less than 3 percent. HHS
set forth in the Executive Order. A This rule is not subject to the welcomes comments concerning the
regulatory impact analysis (RIA) must requirements of Executive Order 13771 impact of this proposed rule on small
be prepared for major rules with because this rule results in no more than manufacturers and small health care
economically significant effects ($100 de minimis costs. providers.
million or more in any 1 year), and a HHS is seeking specific comments on HHS also seeks comments on any
‘‘significant’’ regulatory action is subject the potential financial and other impact impacts of affected parties to reduce by
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six months, the effective date of the List of Subjects in 42 CFR Part 10 loans to community development quota
2017 final rule from July 1, 2019 to Biologics, Business and industry, (CDQ) groups to borrow for traditional
January 1, 2019. Diseases, Drugs, Health, Health care, loan purposes. NMFS also recently
Health facilities, Hospitals. amended its regulations to add the
Unfunded Mandates Reform Act purchase or refinancing of federally
Dated: October 26, 2018. managed harvesting rights in limited
Section 202(a) of the Unfunded George Sigounas,
Mandates Reform Act of 1995 requires access fisheries.
Administrator, Health Resources and Services DATES: The comment period for this
that agencies prepare a written Administration.
statement, which includes an draft rule ends December 17, 2018.
Approved: October 30, 2018.
assessment of anticipated costs and ADDRESSES: You may submit comments,
Alex M. Azar II, identified by NOAA–NMFS–2014–0062,
benefits, before proposing ‘‘any rule that
Secretary, Department of Health and Human by any one of the following methods:
includes any Federal mandate that may
result in the expenditure by State, local,
Services. • Electronic Submissions: Submit all
[FR Doc. 2018–24057 Filed 10–31–18; 11:15 am] electronic public comments via the
and Tribal governments, in the
BILLING CODE 4165–15–P Federal eRulemaking Portal. Go to
aggregate, or by the private sector, of
www.regulations.gov/#!docketDetail;D=
$100 million or more (adjusted annually
NOAA-NMFS-2014-0062, click the
for inflation) in any one year.’’ In 2018, DEPARTMENT OF COMMERCE ‘‘Comment Now!’’ icon, complete the
that threshold is approximately $150 required fields and enter or attach your
million. HHS does not expect this rule National Oceanic and Atmospheric comments.
to exceed the threshold. Administration • Fax: 301–713–1305, Attn: Earl
Executive Order 13132—Federalism Bennett;
50 CFR Part 253 • Mail: Earl Bennett, Program Leader,
HHS has reviewed this proposed rule [Docket No. 180220192–8192–01] FFP, Financial Services Division,
in accordance with Executive Order NMFS, Attn: F/MB5, 1315 East West
13132 regarding federalism, and has RIN 0648–BH82 Highway, SSMC3, Silver Spring, MD
determined that it does not have 20910.
Shipping Act, Merchant Marine, and Instructions: All comments received
‘‘federalism implications.’’ This rule Magnuson-Stevens Fishery
would not ‘‘have substantial direct are a part of the public record and will
Conservation and Management Act generally be posted to http://
effects on the States, or on the (Magnuson-Stevens Act) Provisions;
relationship between the national www.regulations.gov without change.
Fishing Vessel, Fishing Facility and All Personal Identifying Information (for
government and the States, or on the Individual Fishing Quota Lending example, name, address, etc.)
distribution of power and Program voluntarily submitted by the commenter
responsibilities among the various
AGENCY: National Marine Fisheries may be publicly accessible. Do not
levels of government.’’ The proposal to
Service (NMFS), National Oceanic and submit Confidential Business
rescind the June 5, 2018 final rule and Information or otherwise sensitive or
Atmospheric Administration (NOAA),
make the January 5, 2017 final rule protected information. Attachments to
Commerce.
effective as of January 1, 2019 would not electronic comments will be accepted in
adversely affect the following family ACTION: Proposed rule.
Microsoft Word, Excel, WordPerfect, or
elements: Family safety, family stability, SUMMARY: The NMFS’ Fisheries Finance Adobe PDF file formats only.
marital commitment; parental rights in Program (FFP or Program) proposes to FOR FURTHER INFORMATION CONTACT: Earl
the education, nurture, and supervision revise the operating rules of the Program Bennett, NMFS, Fisheries Finance
of their children; family functioning, and set forth procedures, eligibility Program, 301–427–8765.
disposable income or poverty; or the criteria, loan terms, and other SUPPLEMENTARY INFORMATION:
behavior and personal responsibility of requirements to add FFP financing to
youth, as determined under Section construct fishing vessels or reconstruct Electronic Access
654(c) of the Treasury and General fishing vessels in limited access This proposed rule is also accessible
Government Appropriations Act of fisheries that are neither overfished or at http://www.gpoaccess.gov/fr.
1999. HHS invites additional comments subject to overfishing. NMFS believes
on the impact of this proposed rule from that this change will help preserve the Background
affected stakeholders. economic benefits the nation derives Since 1997, the FFP has provided
from its commercial fishing fleets. Aging direct loans (loan guarantees prior to
Paperwork Reduction Act fishing vessels will need to be replaced. that) at 2 percentage points above the
The Paperwork Reduction Act of 1995 This will allow the FFP to play a small Treasury borrowing rate. All FFP vessel
role in this process. Additionally, new loans are collateralized by the fishing
(44 U.S.C. 3507(d)) requires that OMB
fishing vessels will provide a safer vessel, and often include additional
approve all collections of information
environment for fishing crews and will collateral and/or guarantees. The
by a Federal agency from the public be more fuel efficient. The rule provides creditworthiness of borrowers is also
before they can be implemented. This for controls over the uses of replaced examined to ensure their ability to repay
proposed rule is projected to have no vessels that might otherwise contribute the loan. These provide a means of
impact on current reporting and to additional harvesting efforts that recovery in the event of a payment
recordkeeping burden for manufacturers could lead to overfishing. Currently, the default. To date, less than one percent
under the 340B Program. Changes Program provides loans to purchase, of borrowers have defaulted.
proposed in this rule would result in no refurbish, or refinance fishing vessels, In 2016, Congress passed section 302
new reporting burdens. Comments are fish processing facilities, aquaculture of the Coast Guard Authorization Act of
welcome on the accuracy of this facilities and individual fishing quota 2015 (the ‘‘Act’’) (Pub. L. 114–120)
statement. (IFQ) permits. The program also offers which included specific authority for
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Document Created: 2018-11-02 01:09:08
Document Modified: 2018-11-02 01:09:08
| 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 | Proposed Rules | |
| Action | Notice of proposed rulemaking; effective date change. | |
| Dates | Submit comments on or before November 23, 2018 | |
| Contact | CAPT Krista Pedley, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353. | |
| FR Citation | 83 FR 55135 | |
| RIN Number | 0906-AB19 | |
| CFR Associated | Biologics; Business and Industry; Diseases; Drugs; Health; Health Care; Health Facilities and Hospitals |
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