Ohio Regulatory Program, 46703-46705 [2019-19163]

Download as PDF Federal Register / Vol. 84, No. 172 / Thursday, September 5, 2019 / Proposed Rules Containing Natural Health ProductsAssessing the Potential Risk of Liver Injury (Hepatotoxicity),’’ December 12, 2017. Available at https:// www.canada.ca/en/health-canada/ services/drugs-health-products/ medeffect-canada/safety-reviews/greentea-extract-containing-natural-healthproducts-assessing-potential-risk-liverinjury.html. 26. *FDA Import Alert 54–07. Available at https://www.accessdata.fda.gov/cms_ia/ importalert_139.html. 27. Garon, E.B., et al. ‘‘Dichloroacetate Should be Considered with Platinumbased Chemotherapy in Hypoxic Tumors Rather Than as a Single Agent in Advanced Non-small Cell Lung Cancer,’’ Journal of Cancer Research and Clinical Oncology, 140:443, 2014. 28. Shoemaker, R.C., et al. ‘‘Vasoactive Intestinal Polypeptide (VIP) Corrects Chronic Inflammatory Response Syndrome (CIRS) Acquired Following Exposure to Water-Damaged Buildings,’’ Health, 5:396–401, 2013. Available at https://www.scirp.org/journal/health/. (Open Access) 29. *Amendments to the List of Bulk Drug Substances that Can be Used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act, Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis, 2018. Available at https:// www.fda.gov/AboutFDA/Reports ManualsForms/Reports/Economic Analyses/default.htm. List of Subjects in 21 CFR Part 216 Drugs, Prescription drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 216 be amended as follows: PART 216—HUMAN DRUG COMPOUNDING 1. The authority citation for part 216 continues to read as follows: ■ Authority: 21 U.S.C. 351, 352, 353a, 353b, 355, and 371. 2. In § 216.23, revise paragraphs (a) and (b) to read as follows: ■ khammond on DSKBBV9HB2PROD with PROPOSALS § 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. (a) The following bulk drug substances, which are neither the subject of a current applicable United States Pharmacopeia or National Formulary monograph nor components of FDA-approved drugs, can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act. VerDate Sep<11>2014 16:28 Sep 04, 2019 Jkt 247001 (1) Brilliant Blue G, also known as Coomassie Brilliant Blue G–250. (2) Cantharidin (for topical use only). (3) Diphenylcyclopropenone (for topical use only). (4) Glutaraldehyde (for topical use only, in concentrations of 10 percent or lower). (5) Glycolic acid (for topical use only, in concentrations of 70 percent or lower). (6) L-citrulline (for oral administration only). (7) N-acetyl-D-glucosamine (for topical use only). (8) Pyruvic acid (for topical use only). (9) Squaric acid dibutyl ester (for topical use only). (10) Thymol iodide (for topical use only). (11) Trichloroacetic acid (for topical use only). (b) The following bulk drug substances have been nominated and evaluated for inclusion on the list of substance that can be used in compounding set forth in paragraph (a) of this section, and FDA has determined that they do not meet the criteria for inclusion set forth in paragraph (c) of this section: (1) 7-keto dehydroepiandrosterone (DHEA). (2) Acetyl L Carnitine. (3) Alanyl L Glutamine. (4) Aloe Vera 200:1 Freeze Dried. (5) Artemisinin. (6) Astragalus extract 10:1. (7) Boswellia. (8) Cesium Chloride. (9) Chondroitin Sulfate. (10) Chrysin. (11) Curcumin. (12) D-Ribose. (13) Deoxy-D-Glucose. (14) Diindolylmethane. (15) Domperidone. (16) Epigallocatechin gallate (EGCG). (17) Germanium Sesquioxide. (18) Glycyrrhizin. (19) Kojic acid. (20) Nettle. (21) Nicotinamide adenine dinucleotide (NAD). (22) Nicotinamide adenine dinucleotide disodium reduced (NADH). (23) Oxitriptan. (24) Piracetam. (25) Rubidium Chloride. (26) Silver Protein Mild. (27) Sodium dichloroacetate. (28) Tranilast. (29) Vanadyl sulfate. (30) Vasoactive intestinal peptide. * * * * * PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 46703 Dated: July 16, 2019. Norman E. Sharpless, Acting Commissioner of Food and Drugs. Dated: August 13, 2019. Eric D. Hargan, Deputy Secretary, Department of Health and Human Services. [FR Doc. 2019–18951 Filed 9–4–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [OH–262–FOR; Docket ID: OSM–2019–0006 S1D1S SS08011000 SX064A000 190S180110; S2D2S SS08011000 SX064A000 19XS501520] Ohio Regulatory Program Office of Surface Mining Reclamation and Enforcement (OSMRE), Interior. ACTION: Proposed rule; public comment period and opportunity for public hearing. AGENCY: We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are announcing receipt of a proposed amendment to the Ohio regulatory program, hereinafter the Ohio program, under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Ohio seeks to amend its program by revising a definition involving the transfer, assignment, or sale of permit rights. This document gives the times and locations that the Ohio program and this proposed amendment to that program are available for your inspection, the comment period during which you may submit written comments, on the amendment and the procedures that we will follow for the public hearing, if one is requested. DATES: We will accept written comments on this request until 4:00 p.m., Eastern Standard Time (e.s.t.), October 7, 2019. If requested, we will hold a public hearing on the request on September 30, 2019. We will accept requests to speak at a hearing until 4:00 p.m., e.s.t. on September 20, 2019. ADDRESSES: You may submit comments, identified by SATS No. OH–262–FOR, Docket ID: OSM–2019–0006, by any of the following methods: • Mail/Hand Delivery: Mr. Ben Owens, Chief, Pittsburgh Field Division Office of Surface Mining Reclamation and Enforcement 3 Parkway Center, Pittsburgh, Pa 15220. SUMMARY: E:\FR\FM\05SEP1.SGM 05SEP1 46704 Federal Register / Vol. 84, No. 172 / Thursday, September 5, 2019 / Proposed Rules • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Instructions: All submissions received must include the agency name and docket number for this rulemaking. For detailed instructions on submitting comments and additional information on the rulemaking process, see the ‘‘Public Comment Procedures’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to review copies of the Ohio program, this request, a listing of any scheduled public hearings, and all written comments received in response to this document, you must go to the address listed below during normal business hours, Monday through Friday, excluding holidays. You may receive one free copy of the request by contacting OSMRE’s Pittsburgh Field Division or the full text of the request is available for you to read at www.regulations.gov. Mr. Ben Owens, Chief, Pittsburgh Field Division, Office of Surface Mining Reclamation and Enforcement, 3 Parkway Center, Pittsburgh, PA 15220, Telephone: (412) 937–2827, Email: bowens@osmre.gov. In addition, you may review a copy of the request during regular business hours at the following location: Mr. Larry E. Erdos, Chief, Division of Mineral Resources Management, Ohio Department of Natural Resources, 2045 Morse Rd., Building H–2, Columbus, OH 43229–6693, Telephone: (614) 265–6633, Email: lanny.erdos@dnr.state.oh.us. FOR FURTHER INFORMATION CONTACT: Mr. Ben Owens, Chief, Pittsburgh Field Division, Office of Surface Mining Reclamation and Enforcement, 3 Parkway Center, Pittsburgh, PA 15220, Telephone: (412) 937–2827, Email: bowens@osmre.gov. SUPPLEMENTARY INFORMATION: I. Background on the Ohio Program II. Description of the Request III. Public Comment Procedures IV. Procedural Determinations khammond on DSKBBV9HB2PROD with PROPOSALS I. Background on the Ohio Program Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis VerDate Sep<11>2014 16:28 Sep 04, 2019 Jkt 247001 of these criteria, the Secretary of the Interior conditionally approved the Ohio program on August 16, 1982. You can find additional background information on the Ohio program, including the Secretary’s findings, the disposition of comments, and conditions of approval in the August 10, 1982, Federal Register, 47 FR 34688. You can also find later actions concerning Ohio’s program and program amendments at 30 CFR 935.11 and 935.15. II. Description of the Request By letter dated April 11, 2019, Ohio sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq.) that involves the regulatory definition of ‘‘transfer, assignment, or sale of permit rights’’ related to coal mining operations (Administrative Record No. OH–2198). Ohio seeks to add regulatory language at Chapter 1501:13–1–02, Definitions, section (VVVVVV) of the Ohio Administrative Code, which currently defines the term as ‘‘a change of a permittee, including, but not limited to, any fundamental legal change in the structure or nature of a permittee, or a name change.’’ With this amendment, Ohio seeks to expand the definition to include a change in the ownership and operational control of a permittee to a person who has not held a permit issued under Chapter 1513, Coal Surface Mining, of the Ohio Revised Code (ORC) for a period of not less than five years where the existence and name of the permittee remain the same. Ohio states that this change is intended to prevent a person who is not eligible to participate in the bond pool under section 1513.08(C)(2) of the ORC from gaining access to the bond pool through a change of ownership and operational control that does not change the existence and name of the permittee. Ohio states that requiring such a person to apply for a transfer, assignment, or sale of permit rights will assure that all performance security requirements are met. The full text of the amendment is available for you to read at the locations listed above under ADDRESSES or at www.regulations.gov. III. Public Comment Procedures Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether this amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the State program. PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 Electronic or Written Comments If you submit written or electronic comments on the request during the 30day comment period, they should be specific, confined to issues pertinent to the request, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence our decision will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications. We cannot ensure that comments received after the close of the comment period (see DATES) or sent to an address other than those listed (see ADDRESSES) will be included in the docket for this rulemaking and considered. Public Availability of Comments Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Public Hearing If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., e.s.t. on September 20, 2019. If you are disabled and need reasonable accommodations to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT. We will arrange the location and time of the hearing with those persons requesting the hearing. If no one requests an opportunity to speak, we will not hold a hearing. To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak, and others present in the audience who wish to speak, have been heard. E:\FR\FM\05SEP1.SGM 05SEP1 Federal Register / Vol. 84, No. 172 / Thursday, September 5, 2019 / Proposed Rules Public Meeting If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under FOR FURTHER INFORMATION CONTACT. All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES. We will make a written summary of each meeting a part of the administrative record. IV. Procedural Determinations khammond on DSKBBV9HB2PROD with PROPOSALS Executive Order 12866—Regulatory Planning and Review and Executive Order 13563—Improving Regulation and Regulatory Review Executive Order 12866 provides that the Office of Information and Regulatory VerDate Sep<11>2014 16:28 Sep 04, 2019 Jkt 247001 46705 Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993, the approval of State program amendments is exempted from OMB review under Executive Order 12866. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption. comment period and determine whether the amendment should be approved, approved in part, or not approved. At that time, we will also make the determinations and certifications required by the various laws and executive orders governing the rulemaking process and include them in the final rule. Other Laws and Executive Orders Affecting Rulemaking List of Subjects in 30 CFR Part 935 When a State submits a program amendment to OSMRE for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the Federal Register indicating receipt of the proposed amendment, its text or a summary of its terms, and an opportunity for public comment. We conclude our review of the proposed amendment after the close of the public PO 00000 Frm 00018 Fmt 4702 Sfmt 9990 Intergovernmental relations, Surface mining, Underground mining. Dated: June 4, 2019. Thomas D. Shope, Regional Director, Appalachian Region. [FR Doc. 2019–19163 Filed 9–4–19; 8:45 am] BILLING CODE 4310–05–P E:\FR\FM\05SEP1.SGM 05SEP1

Agencies

[Federal Register Volume 84, Number 172 (Thursday, September 5, 2019)]
[Proposed Rules]
[Pages 46703-46705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19163]


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DEPARTMENT OF INTERIOR

Office of Surface Mining Reclamation and Enforcement

30 CFR Part 935

[OH-262-FOR; Docket ID: OSM-2019-0006 S1D1S SS08011000 SX064A000 
190S180110; S2D2S SS08011000 SX064A000 19XS501520]


Ohio Regulatory Program

AGENCY: Office of Surface Mining Reclamation and Enforcement (OSMRE), 
Interior.

ACTION: Proposed rule; public comment period and opportunity for public 
hearing.

-----------------------------------------------------------------------

SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement 
(OSMRE), are announcing receipt of a proposed amendment to the Ohio 
regulatory program, hereinafter the Ohio program, under the Surface 
Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Ohio 
seeks to amend its program by revising a definition involving the 
transfer, assignment, or sale of permit rights. This document gives the 
times and locations that the Ohio program and this proposed amendment 
to that program are available for your inspection, the comment period 
during which you may submit written comments, on the amendment and the 
procedures that we will follow for the public hearing, if one is 
requested.

DATES: We will accept written comments on this request until 4:00 p.m., 
Eastern Standard Time (e.s.t.), October 7, 2019. If requested, we will 
hold a public hearing on the request on September 30, 2019. We will 
accept requests to speak at a hearing until 4:00 p.m., e.s.t. on 
September 20, 2019.

ADDRESSES: You may submit comments, identified by SATS No. OH-262-FOR, 
Docket ID: OSM-2019-0006, by any of the following methods:
     Mail/Hand Delivery: Mr. Ben Owens, Chief, Pittsburgh Field 
Division Office of Surface Mining Reclamation and Enforcement 3 Parkway 
Center, Pittsburgh, Pa 15220.

[[Page 46704]]

     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. For detailed instructions on 
submitting comments and additional information on the rulemaking 
process, see the ``Public Comment Procedures'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to review copies of the Ohio 
program, this request, a listing of any scheduled public hearings, and 
all written comments received in response to this document, you must go 
to the address listed below during normal business hours, Monday 
through Friday, excluding holidays. You may receive one free copy of 
the request by contacting OSMRE's Pittsburgh Field Division or the full 
text of the request is available for you to read at 
www.regulations.gov.

Mr. Ben Owens, Chief, Pittsburgh Field Division, Office of Surface 
Mining Reclamation and Enforcement, 3 Parkway Center, Pittsburgh, PA 
15220, Telephone: (412) 937-2827, Email: [email protected].

    In addition, you may review a copy of the request during regular 
business hours at the following location:

Mr. Larry E. Erdos, Chief, Division of Mineral Resources Management, 
Ohio Department of Natural Resources, 2045 Morse Rd., Building H-2, 
Columbus, OH 43229-6693, Telephone: (614) 265-6633, Email: 
[email protected].

FOR FURTHER INFORMATION CONTACT: Mr. Ben Owens, Chief, Pittsburgh Field 
Division, Office of Surface Mining Reclamation and Enforcement, 3 
Parkway Center, Pittsburgh, PA 15220, Telephone: (412) 937-2827, Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
I. Background on the Ohio Program
II. Description of the Request
III. Public Comment Procedures
IV. Procedural Determinations

I. Background on the Ohio Program

    Section 503(a) of the Act permits a State to assume primacy for the 
regulation of surface coal mining and reclamation operations on non-
Federal and non-Indian lands within its borders by demonstrating that 
its State program includes, among other things, State laws and 
regulations that govern surface coal mining and reclamation operations 
in accordance with the Act and consistent with the Federal regulations. 
See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the 
Secretary of the Interior conditionally approved the Ohio program on 
August 16, 1982. You can find additional background information on the 
Ohio program, including the Secretary's findings, the disposition of 
comments, and conditions of approval in the August 10, 1982, Federal 
Register, 47 FR 34688. You can also find later actions concerning 
Ohio's program and program amendments at 30 CFR 935.11 and 935.15.

II. Description of the Request

    By letter dated April 11, 2019, Ohio sent us an amendment to its 
program under SMCRA (30 U.S.C. 1201 et seq.) that involves the 
regulatory definition of ``transfer, assignment, or sale of permit 
rights'' related to coal mining operations (Administrative Record No. 
OH-2198). Ohio seeks to add regulatory language at Chapter 1501:13-1-
02, Definitions, section (VVVVVV) of the Ohio Administrative Code, 
which currently defines the term as ``a change of a permittee, 
including, but not limited to, any fundamental legal change in the 
structure or nature of a permittee, or a name change.'' With this 
amendment, Ohio seeks to expand the definition to include a change in 
the ownership and operational control of a permittee to a person who 
has not held a permit issued under Chapter 1513, Coal Surface Mining, 
of the Ohio Revised Code (ORC) for a period of not less than five years 
where the existence and name of the permittee remain the same. Ohio 
states that this change is intended to prevent a person who is not 
eligible to participate in the bond pool under section 1513.08(C)(2) of 
the ORC from gaining access to the bond pool through a change of 
ownership and operational control that does not change the existence 
and name of the permittee. Ohio states that requiring such a person to 
apply for a transfer, assignment, or sale of permit rights will assure 
that all performance security requirements are met.
    The full text of the amendment is available for you to read at the 
locations listed above under ADDRESSES or at www.regulations.gov.

III. Public Comment Procedures

    Under the provisions of 30 CFR 732.17(h), we are seeking your 
comments on whether this amendment satisfies the applicable program 
approval criteria of 30 CFR 732.15. If we approve the amendment, it 
will become part of the State program.

Electronic or Written Comments

    If you submit written or electronic comments on the request during 
the 30-day comment period, they should be specific, confined to issues 
pertinent to the request, and explain the reason for any recommended 
change(s). We appreciate any and all comments, but those most useful 
and likely to influence our decision will be those that either involve 
personal experience or include citations to and analyses of SMCRA, its 
legislative history, its implementing regulations, case law, other 
pertinent State or Federal laws or regulations, technical literature, 
or other relevant publications.
    We cannot ensure that comments received after the close of the 
comment period (see DATES) or sent to an address other than those 
listed (see ADDRESSES) will be included in the docket for this 
rulemaking and considered.

Public Availability of Comments

    Before including your address, phone number, email address, or 
other personal identifying information in your comment, you should be 
aware that your entire comment including your personal identifying 
information, may be made publicly available at any time. While you can 
ask us in your comment to withhold your personal identifying 
information from public review, we cannot guarantee that we will be 
able to do so.

Public Hearing

    If you wish to speak at the public hearing, contact the person 
listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., e.s.t. on 
September 20, 2019. If you are disabled and need reasonable 
accommodations to attend a public hearing, contact the person listed 
under FOR FURTHER INFORMATION CONTACT. We will arrange the location and 
time of the hearing with those persons requesting the hearing. If no 
one requests an opportunity to speak, we will not hold a hearing.
    To assist the transcriber and ensure an accurate record, we 
request, if possible, that each person who speaks at the public hearing 
provide us with a written copy of his or her comments. The public 
hearing will continue on the specified date until everyone scheduled to 
speak has been given an opportunity to be heard. If you are in the 
audience and have not been scheduled to speak and wish to do so, you 
will be allowed to speak after those who have been scheduled. We will 
end the hearing after everyone scheduled to speak, and others present 
in the audience who wish to speak, have been heard.

[[Page 46705]]

Public Meeting

    If only one person requests an opportunity to speak, we may hold a 
public meeting rather than a public hearing. If you wish to meet with 
us to discuss the amendment, please request a meeting by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT. All such meetings 
are open to the public and, if possible, we will post notices of 
meetings at the locations listed under ADDRESSES. We will make a 
written summary of each meeting a part of the administrative record.

IV. Procedural Determinations

Executive Order 12866--Regulatory Planning and Review and Executive 
Order 13563--Improving Regulation and Regulatory Review

    Executive Order 12866 provides that the Office of Information and 
Regulatory Affairs in the Office of Management and Budget (OMB) will 
review all significant rules. Pursuant to OMB guidance, dated October 
12, 1993, the approval of State program amendments is exempted from OMB 
review under Executive Order 12866. Executive Order 13563, which 
reaffirms and supplements Executive Order 12866, retains this 
exemption.

Other Laws and Executive Orders Affecting Rulemaking

    When a State submits a program amendment to OSMRE for review, our 
regulations at 30 CFR 732.17(h) require us to publish a notice in the 
Federal Register indicating receipt of the proposed amendment, its text 
or a summary of its terms, and an opportunity for public comment. We 
conclude our review of the proposed amendment after the close of the 
public comment period and determine whether the amendment should be 
approved, approved in part, or not approved. At that time, we will also 
make the determinations and certifications required by the various laws 
and executive orders governing the rulemaking process and include them 
in the final rule.

List of Subjects in 30 CFR Part 935

    Intergovernmental relations, Surface mining, Underground mining.

    Dated: June 4, 2019.
Thomas D. Shope,
Regional Director, Appalachian Region.
[FR Doc. 2019-19163 Filed 9-4-19; 8:45 am]
BILLING CODE 4310-05-P