83 FR 20008 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 88 (May 7, 2018)
Federal Register Volume 83, Issue 88 (May 7, 2018)
| Page Range | 20008-20011 | |
| FR Document | 2018-09711 |
[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)] [Proposed Rules] [Pages 20008-20011] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09711] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 10 RIN 0906-AB18 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of proposed rulemaking; further delay of effective date. ----------------------------------------------------------------------- SUMMARY: The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the [[Page 20009]] effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. DATES: Submit comments on or before May 22, 2018. ADDRESSES: You may submit comments, identified by the Regulatory Information Number (RIN) 0906-AB18, by any of the following methods. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions.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-AB11in 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 comments submitted will be available to the public in their entirety. Please do not submit confidential commercial information or personally 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) on June 17, 2015, to implement civil monetary penalties (CMPs) for manufacturers that 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 to establish the requirement that a manufacturer charge $.01 (penny pricing) for each unit of a drug when the ceiling price calculation equals zero (80 FR 34583, June 17, 2015). 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. On January 5, 2017, HHS published a final rule in the Federal Register (82 FR 1210, January 5, 2017); comments from both the original comment period established in the NPRM and the reopened comment period announced in the April 19, 2016, notice were considered in the development of the final rule. The provisions of that final rule were to be effective March 6, 2017; however, HHS issued a subsequent final rule (82 FR 12508, March 6, 2017) delaying the effective date to March 21, 2017, in accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, titled ``Regulatory Freeze Pending Review.'' \1\ --------------------------------------------------------------------------- \1\ See: https://www.whitehouse.gov/the-press-office/2017/01/20/memorandum-heads-executive-departments-and-agencies. --------------------------------------------------------------------------- To provide affected parties sufficient time to make needed changes to facilitate compliance, and because questions were raised, HHS issued an interim final rule (82 FR 14332, March 20, 2017) to delay the effective date of the final rule to May 22, 2017. HHS solicited additional comments on whether that date should be further extended to October 1, 2017. After careful consideration of the comments received, HHS delayed the effective date of the January 5, 2017, final rule to October 1, 2017 (82 FR 22893, May 19, 2017). HHS later solicited comment on delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553, August 21, 2017). After consideration of the comments received, HHS delayed the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 45511, September 29, 2017). II. Proposal To Delay the Effective Date of the Final Rule HHS proposes to further delay the effective date of the January 5, 2017, final rule as HHS intends to engage in additional or alternative rulemaking on these issues, and as discussed in more detail on page 5, the Department believes it would be counterproductive to effectuate the final rule prior to issuance of additional or alternative rulemaking on these issues. HHS is in the process of developing new comprehensive policies to address the rising costs of prescription drugs. Those policies will address drug pricing in government programs, such as Medicare Parts B & D, Medicaid, and the 340B discount drug program. Accordingly, we are proposing to delay the effective date of the final rule entitled ``340B Drug Pricing Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.'' See 82 FR 1210 (Jan. 5, 2017). This rule is currently scheduled to go into effect on July 1, 2018; we are proposing to delay further the effective date to July 1, 2019. We do not believe that this delay will adversely affect any of the stakeholders in a meaningful way. The final rule implements both penny pricing and a provision in the Affordable Care Act contemplating civil money penalties for those who fail to provide the proper 340B discounts to covered entities. The so-called penny pricing provision would allow manufacturers to charge $0.01 for a drug with when the ceiling price calculation results in a zero amount. As discussed in the January 5, 2017 final rule, a small number of manufacturers have informed HHS over the last several years that they charge more than $0.01 for a drug with a ceiling price below $0.01. However, this is a long-standing HHS policy, and HHS believes the majority of manufacturers currently follow the practice of charging a $0.01. Therefore, the delay of this portion of the regulation would not result in a significant economic impact. Delaying implementation of the 340B-specific CMPs should have no adverse effect given that other more significant remedies are available to entities that believe that they have not been provided the full discount that they are entitled to receive under the program. This proposed delay, though, will save the healthcare sector compliance costs, as described in the January 5, 2017 issuance of the final rule. HHS believes that the proposed delay would allow necessary time to consider more fully the substantial questions of fact, law, and policy identified by the Department during its review of the rule pursuant to the aforementioned ``Regulatory Freeze Pending Review,'' memorandum. Requiring manufacturers to make targeted and potentially costly changes to pricing systems and business procedures to comply with a rule that is under further consideration would be disruptive. [[Page 20010]] As background, the January 20, 2017, Executive Order entitled, ``Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal,'' specifically instructs HHS and all other heads of executive offices to utilize all authority and discretion available to delay the implementation of certain provisions or requirements of the Patient Protection and Affordable Care Act.\2\ The January 5, 2017, final rule is based on changes made to the 340B Program by the Patient Protection and Affordable Care Act. HHS is proposing to further delay the effective date of the January 5, 2017, final rule to July 1, 2019, to more fully consider the regulatory burdens that may be posed by this final rule. --------------------------------------------------------------------------- \2\ See: https://www.thefederalregister.org/fdsys/pkg/FR-2017-01-24/pdf/2017-01799.pdf. --------------------------------------------------------------------------- At this time, HHS seeks public comment regarding the impact of delaying the effective date of the final rule, published January 5, 2017, for an additional 12 months from the current effective date of July 1, 2018, to Ju1y 1, 2019, while a more deliberate rulemaking process is undertaken. HHS is soliciting public comments for a shortened 15-day period because parties have had ample opportunity to comment on the two prior delays of the effective date of the underlying 340B regulation, and the impact of this delay on the regulated community is de minimis. Given the prior opportunities to comment on the underlying proposed regulation and the delays, we do not envision receiving any novel comments. Moreover, we believe that the delay of the CMP authority can be issued without the opportunity for public comment because it delays the effective date of a regulatory restriction. HHS encourages all stakeholders to provide comments on this proposed rule. 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 (Pub. L. 96- 354, September 19, 1980), 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 one 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 must be prepared for major rules with economically significant effects ($100 million or more in any one 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 further delay the effective date of the January 5, 2017, final rule will have an economic impact of $100 million or more, and therefore, this NPRM has not been designated as an ``economically significant'' proposed rule under section 3(f)(1) of the Executive Order 12866. The economic impact of having no rule in place related to the policies addressed in the final rule is believed to be minimal. Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. This action's designation as regulatory or deregulatory will be discussed in the final rule and be informed by comments received in response to this proposed rule. 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 for 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 3 percent impact on at least 5 percent of small entities. For purposes of the RFA, HHS considers all health care providers to be small entities either by meeting the Small Business Administration (SBA) size standard for a small business, or by 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, 2018, over 12,800 covered entities participate in the 340B Program, representing safety-net health care providers across the country. HHS has determined, and the Secretary certifies, that this proposed rule would 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 this RFA. HHS estimates that the economic impact on small entities and small manufacturers would be minimal. HHS welcomes comments concerning the impact of this proposed rule on small manufacturers. 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 2017, the threshold level was approximately $148 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 proposed 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 [[Page 20011]] responsibilities among the various levels of government.'' 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. This proposed rule would result in no new reporting burdens. Comments are welcome on the accuracy of this statement. Dated: May 1, 2018. George Sigounas, Administrator, Health Resources and Services Administration. Approved: May 2, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2018-09711 Filed 5-4-18; 8:45 am] BILLING CODE 4165-15-P
![20008 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
criteria, and advances in knowledge Additional instructions on low-income populations, in the
showing scientific concerns with the commenting or visiting the docket, development, implementation, and
logic underpinning the criteria as along with more information about enforcement of environmental laws,
constructed in 1994, the Agency cannot dockets generally, is available at http:// regulations, and policies. To help
utilize the proposed criteria as a basis www.epa.gov/dockets. address potential environmental justice
for this rulemaking. EPA is therefore FOR FURTHER INFORMATION CONTACT: issues, the Agency seeks information on
withdrawing this proposal. Michael Goodis, Director, Registration any groups or segments of the
3. Where can I get more information Division (RD) (7505P), Office of population who, as a result of their
about this action? The docket for this Pesticide Programs, Environmental location, cultural practices, or other
action is available under docket ID Protection Agency, 1200 Pennsylvania factors, may have atypical or
number OPP–300369. See also related Ave. NW, Washington, DC 20460–0001; disproportionately high and adverse
dockets identified by the docket ID main telephone number: (703) 305– human health impacts or environmental
numbers OPP–300370 and OPP–300371. 7090; email address: RDFRNotices@ effects from exposure to the pesticides
Authority: 7 U.S.C. 136 et seq., 21 U.S.C. epa.gov. discussed in this document, compared
346. to the general population.
SUPPLEMENTARY INFORMATION:
Dated: April 25, 2018. II. What Does this Correction Do?
Charlotte Bertrand, I. General Information
This notice is being issued to correct
Acting Principal Deputy Assistant A. Does this action apply to me? PP 7E8571. (EPA–HQ–OPP–2017–0291)
Administrator, Office of Chemical Safety and
Pollution Prevention. You may be potentially affected by in FR Doc. 2017–19692, published in
this action if you are an agricultural the Federal Register of September 15,
[FR Doc. 2018–09206 Filed 5–4–18; 8:45 am]
producer, food manufacturer, or 2017 (82 FR 43352) (FRL–9965–43) is
BILLING CODE 6560–50–P
pesticide manufacturer. The following corrected as follows:
list of North American Industrial PP 7E8571. (EPA–HQ–OPP–2017–
ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is 0291). Syngenta Crop Protection, LLC,
AGENCY not intended to be exhaustive, but rather P.O. Box 18300, Greensboro, NC 27419,
provides a guide to help readers requests to establish a tolerance in 40
40 CFR Part 180 determine whether this document CFR 180.226 for residues of the
applies to them. Potentially affected herbicide, diquat (6,7-dihydrodipyrido
[EPA–HQ–OPP–2017–0291; FRL–9976–34] entities may include: [1,2-a:2′1′-c] pyrazinediium), and its
• Crop production (NAICS code 111). metabolites in or on Crop Group 6C,
Receipt of a Pesticide Petition Filed for
• Animal production (NAICS code dried shelled pea and bean (except
Residues of Diquat in or on Crop
112). soybean) at 0.9 parts per million (ppm).
Group 6C, Dried Shelled Pea and Bean • Food manufacturing (NAICS code
(Except Soybean); Correction The Method GRM012.03A is used to
311). measure and evaluate the chemical
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS residues of diquat dibromide in
Agency (EPA). code 32532). commodities. Contact: RD.
ACTION: Notice; correction. B. What should I consider as I prepare Authority: 21 U.S.C. 346a.
SUMMARY: EPA issued a notice in the my comments for EPA? Dated: April 26, 2018.
Federal Register of September 15, 2017, 1. Submitting CBI. Do not submit this Michael Goodis,
announcing the initial filing of a information to EPA through Director, Registration Division, Office of
pesticide petition requesting the regulations.gov or email. Clearly mark Pesticide Programs.
establishment or modification of the part or all of the information that [FR Doc. 2018–09648 Filed 5–4–18; 8:45 am]
regulations for residues of pesticide you claim to be CBI. For CBI BILLING CODE 6560–50–P
chemicals in or on various commodities. information in a disk or CD–ROM that
DATES: Comments must be received on you mail to EPA, mark the outside of the
or before June 6, 2018. disk or CD–ROM as CBI and then DEPARTMENT OF HEALTH AND
ADDRESSES: Submit your comments, identify electronically within the disk or HUMAN SERVICES
identified by docket identification (ID) CD–ROM the specific information that
number EPA–HQ–OPP–2017–0291, by is claimed as CBI. In addition to one 42 CFR Part 10
one of the following methods: complete version of the comment that
RIN 0906–AB18
• Federal eRulemaking Portal: http:// includes information claimed as CBI, a
www.regulations.gov. Follow the online copy of the comment that does not
340B Drug Pricing Program Ceiling
instructions for submitting comments. contain the information claimed as CBI
Price and Manufacturer Civil Monetary
Do not submit electronically any must be submitted for inclusion in the
Penalties Regulation
information you consider to be public docket. Information so marked
Confidential Business Information (CBI) will not be disclosed except in AGENCY: Health Resources and Services
or other information whose disclosure is accordance with procedures set forth in Administration, HHS.
restricted by statute. 40 CFR part 2. ACTION: Notice of proposed rulemaking;
• Mail: OPP Docket, Environmental 2. Tips for preparing your comments. further delay of effective date.
daltland on DSKBBV9HB2PROD with PROPOSALS
Protection Agency Docket Center (EPA/ When preparing and submitting your
DC), (28221T), 1200 Pennsylvania Ave. comments, see the commenting tips at SUMMARY: The Health Resources and
NW, Washington, DC 20460–0001. http://www.epa.gov/dockets/ Services Administration (HRSA)
• Hand Delivery: To make special comments.html. administers section 340B of the Public
arrangements for hand delivery or 3. Environmental justice. EPA seeks to Health Service Act, referred to as the
delivery of boxed information, please achieve environmental justice, the fair ‘‘340B Drug Pricing Program’’ or the
follow the instructions at http:// treatment and meaningful involvement ‘‘340B Program.’’ HHS is soliciting
www.epa.gov/dockets/contacts.html. of any group, including minority and/or comments on further delaying the
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![Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules 20011
responsibilities among the various DATES: Submit comments on or before comments and reply comments on or
levels of government.’’ July 6, 2018. Submit reply comments before the dates indicated on the first
August 6, 2018. page of this document. Comments may
Paperwork Reduction Act
ADDRESSES: You may submit comments, be filed using the Commission’s
The Paperwork Reduction Act of 1995 identified by WP Docket No. 07–100 by Electronic Comment Filing System
(44 U.S.C. 3507(d)) requires that OMB any of the following methods: (ECFS). See Electronic Filing of
approve all collections of information • Federal Communications Documents in Rulemaking Proceedings,
by a federal agency from the public Commission’s website: http:// 63 FR 24121, May 1 (1998).
before they can be implemented. This apps.fcc.gov/ecfs/. Follow the • Electronic Filers: Comments may be
proposed rule is projected to have no instructions for submitting comments. filed electronically using the internet by
impact on current reporting and • Mail: U.S. Postal Service first-class, accessing the ECFS: http://apps.fcc.gov/
recordkeeping burden for manufacturers Express, and Priority mail must be ecfs/.
under the 340B Program. This proposed addressed to 445 12th Street SW, • Paper Filers: Parties who choose to
rule would result in no new reporting Washington, DC 20554. Commercial file by paper must file an original and
burdens. Comments are welcome on the overnight mail (other than U.S. Postal one copy of each filing. If more than one
accuracy of this statement. Service Express Mail and Priority Mail) docket or rulemaking number appears in
Dated: May 1, 2018. must be sent to 9050 Junction Drive, the caption of this proceeding, filers
Annapolis Junction, MD 20701. must submit two additional copies for
George Sigounas,
• Hand or Messenger Delivery: 445 each additional docket or rulemaking
Administrator, Health Resources and Services number.
Administration. 12th St., SW, Room TW–A325,
Washington, DC 20554. Filings can be sent by hand or
Approved: May 2, 2018. messenger delivery, by commercial
• People with Disabilities: Contact the
Alex M. Azar II, overnight courier, or by first-class or
FCC to request reasonable
Secretary, Department of Health and Human overnight U.S. Postal Service mail. All
accommodations (accessible format
Services. filings must be addressed to the
documents, sign language interpreters,
[FR Doc. 2018–09711 Filed 5–4–18; 8:45 am]
CART, etc.) by email: FCC504@fcc.gov Commission’s Secretary, Office of the
BILLING CODE 4165–15–P
or phone: 202–418–0530 or TTY: 202– Secretary, Federal Communications
418–0432. Commission.
For detailed instructions for • All hand-delivered or messenger-
submitting comments and additional delivered paper filings for the
FEDERAL COMMUNICATIONS Commission’s Secretary must be
COMMISSION information on the rulemaking process,
see the SUPPLEMENTARY INFORMATION delivered to FCC Headquarters at 445
47 CFR Parts 0, 2, 90 section of this document. 12th St., SW, Room TW–A325,
Washington, DC 20554. The filing hours
FOR FURTHER INFORMATION CONTACT:
[WP Docket No. 07–100; FCC 18–33] are 8:00 a.m. to 7:00 p.m. All hand
Thomas Eng, Policy and Licensing
deliveries must be held together with
Division, Public Safety and Homeland
4.9 GHz Band rubber bands or fasteners. Any
Security Bureau, Federal
envelopes and boxes must be disposed
AGENCY: Federal Communications Communications Commission, 445 12th
of before entering the building.
Commission. Street SW, Washington, DC 20554, at • Commercial overnight mail (other
ACTION: Proposed rule. (202) 418–0019, TTY (202) 418–7233, or than U.S. Postal Service Express Mail
via email at Thomas.Eng@fcc.gov. and Priority Mail) must be sent to 9050
SUMMARY: In 2002, the Commission SUPPLEMENTARY INFORMATION: This is a Junction Drive, Annapolis Junction, MD
allocated the 4940–4990 MHz (4.9 GHz) summary of the Commission’s Sixth 20701.
band for fixed and mobile use and Further Notice of Proposed Rulemaking • U.S. Postal Service first-class,
designated the band for public safety (Sixth FNPRM) in WP Docket No. 07– Express, and Priority mail must be
broadband communications. Since then, 100, adopted on March 22, 2018 and addressed to 445 12th Street, SW,
the band has experienced relatively released as FCC 18–33 on March 23, Washington DC 20554.
light usage compared to the heavy use 2018. The complete text of this
of other public safety bands. In this document is available for inspection Introduction
document, the Commission proposes and copying during normal business The Commission has allocated and
several rule changes and seeks comment hours in the FCC Reference Information designated 50 megahertz of spectrum in
on alternatives with the goal of Center, Portals II, 445 12th Street SW, the 4.9 GHz band (4940–4990 MHz) to
promoting increased public safety use of Room CY–A257, Washington, DC 20554. public safety. Although nearly 90,000
the band while opening up the spectrum Alternative formats (computer diskette, public safety entities are eligible under
to additional uses that will encourage a large print, audio cassette, and Braille) our rules to obtain licenses in the band,
more robust market for equipment and are available to persons with disabilities there were only 2,442 licenses in use in
greater innovation. The Commission or by sending an email to FCC504@ 2012 and only 3,174 licenses in use
proposes rules on channel aggregation, fcc.gov or calling the Consumer and nearly six years later in 2018. With no
aeronautical mobile use, frequency Governmental Affairs Bureau at (202) more than 3.5% of potential licensees
coordination, site-based licensing, 418–0530, TTY (202) 418–0432. This using the band, we remain concerned
daltland on DSKBBV9HB2PROD with PROPOSALS
regional planning, and technical rule document is also available on the that, as the Commission stated in 2012,
changes with the goal of promoting Commission’s website at http:// the band has ‘‘fallen short of its
increased use of the band. The www.fcc.gov. potential.’’
Commission seeks comment on Public safety entities have offered
alternatives such as expanding Comments several reasons why the band has seen
eligibility, spectrum leasing, sharing, Pursuant to §§ 1.415 and 1.419 of the less use than expected. One reason cited
and redesignating the band for Commission’s rules, 47 CFR 1.415, is the difficulty of acquiring equipment
commercial use. 1.419, interested parties may file and the cost of deployment. According
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Document Created: 2018-05-05 02:48:28
Document Modified: 2018-05-05 02:48:28
| 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; further delay of effective date. | |
| Dates | Submit comments on or before May 22, 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 20008 | |
| RIN Number | 0906-AB18 |
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