Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding Regulations, 17611-17612 [2013-06526]

Download as PDF sroberts on DSK5SPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Proposed Rules us by the production reporting date, an amount equal to the reduction in the yield will be added to the production to count calculated in section 11(c) due to uninsured causes. We may reduce the yield used to establish your production guarantee for the subsequent crop year to reflect any reduction in the productive capacity of the trees. * * * * * 6. * * * In accordance with section 8 of the Basic Provisions, the insured crop will be all the acreage in the county of each citrus fruit group you elect to insure and for which a premium rate is provided by the actuarial documents: * * * * * (f) That is grown on trees that have reached at least: (1) The sixth growing season after being set out, unless otherwise provided in the Special Provisions or if we inspect and approve a written agreement to insure such acreage; or (2) The fifth growing season after topwork, unless otherwise provided in the Special Provisions or if we inspect and approve a written agreement to insure such acreage. 7. Insurable Acreage In lieu of the provisions in section 9 of the Basic Provisions that prohibit insurance attaching to interplanted acreage, citrus interplanted with another perennial agricultural commodity is insurable unless we inspect the acreage and determine it does not meet the requirements contained in your policy. 8. * * * (a) * * * (2) * * * (i) August 31 for: (A) Navel oranges; and (B) Southern California lemons (Imperial, Orange, Riverside, San Bernardino, San Diego, and Ventura Counties); * * * * * 9. * * * (a) * * * * * * * * (7) Insects, but not damage due to insufficient or improper application of pest control measures; or (8) Plant disease, but not damage due to insufficient or improper application of disease control measures. (b) In addition to the causes of loss excluded in section 12 of the Basic Provisions, we will not insure against damage or loss of production due to the inability to market the citrus for any reason other than actual physical damage from an insurable cause of loss specified in this section. For example, we will not pay you an indemnity if you are unable to market due to quarantine, VerDate Mar<15>2010 16:48 Mar 21, 2013 Jkt 229001 boycott, or refusal of any person to accept production. 10. * * * (a) In accordance with the requirements of section 14 of the Basic Provisions, you must leave representative samples in accordance with our procedures. * * * * * 11. * * * * * * * * (f) If you elect the frost protection option and we determine that frost protection equipment, as specified in the Special Provisions, was not properly utilized or not properly reported, the indemnity for the unit will be reduced by the percentage of premium reduction allowed for frost protection equipment. You must, at our request, provide us records showing the start-stop times by date for each period the frost protection equipment was used. * * * * * Signed in Washington, DC, on March 11, 2013. Brandon Willis, Administrator, Federal Crop Insurance Corporation. [FR Doc. 2013–06106 Filed 3–21–13; 8:45 am] BILLING CODE 3410–08–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part Chapter 1 [Docket No. FDA–2013–N–0260] Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding Regulations AGENCY: Food and Drug Administration, HHS. Notification; request for comments. ACTION: SUMMARY: The Food and Drug Administration (FDA) is inviting comments from the public on whether any potential changes to the Federal drug regulations are necessary for medical gases. DATES: Submit electronic or written comments by May 21, 2013. ADDRESSES: Submit electronic comments to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 17611 docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6280, Silver Spring, MD 20993–0002, 301– 796–2465, christine.kirk@fda.hhs.gov; or Germaine Connolly, Center for Veterinary Medicine (HFV–116), Food and Drug Administration, 7500 Standish Pl., MPN2, Rockville, MD 20855, 240–276–8331, germaine. connolly@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, President Obama signed the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112– 144) into law. Section 1112(a) of FDASIA provides that not later than 18 months after its enactment, the Secretary of Health and Human Services, after obtaining input from medical gas manufacturers and any other interested members of the public, shall determine whether any changes to the Federal drug regulations are necessary for medical gases and submit a report regarding any such changes to the Committee on Health, Education, Labor, and Pensions of the U.S. Senate and the Committee on Energy and Commerce of the U.S. House of Representatives. Section 1112(c)(l) defines ‘‘Federal drug regulations’’ to mean ‘‘regulations in title 21 of the Code of Federal Regulations pertaining to drugs.’’ Section 1112(b) provides that if the Secretary determines that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the enactment of FDASIA. FDA is opening this docket to provide the public with an opportunity to submit comments on whether any potential changes to Federal drug regulations are necessary for medical gases. II. Opportunities for Comment on Other Medical Gas Dockets FDASIA also added new sections regarding medical gases to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (see Title XI, Subtitle B, section 1111 of FDASIA, adding new sections 575, 576, and 577 to the FD&C Act). FDA has previously issued two other Federal Register notices related to these new sections. On November 23, 2012 (77 FR 70166), FDA issued a Federal Register notice E:\FR\FM\22MRP1.SGM 22MRP1 17612 Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Proposed Rules establishing a public docket (Docket No. FDA–2012–N–1090) for information pertaining to FDA’s implementation of the provisions of FDASIA related to medical gases. Interested persons may submit comments relevant to that Federal Register notice (see ADDRESSES) under Docket No. FDA–2012–N–1090. On December 18, 2012 (77 FR 74852), FDA issued a notice of availability announcing publication of a draft guidance for industry entitled ‘‘Certification Process for Designated Medical Gases’’ (http://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ UCM332136.pdf) (Docket No. FDA– 2012–D–1197). The draft guidance describes the new certification process created by FDASIA for certain medical gases and explains how FDA plans to implement that process. Interested persons may submit comments regarding the draft guidance (see ADDRESSES) under Docket No. FDA– 2012–D–1197. Please note that although comments on draft guidance may be submitted at any time, FDA requested that comments be submitted by February 19, 2013, in order to allow adequate time for the comments to be considered while the Agency is preparing final guidance. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: March 18, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06526 Filed 3–21–13; 8:45 am] sroberts on DSK5SPTVN1PROD with PROPOSALS BILLING CODE 4160–01–P DEPARTMENT OF THE TREASURY DEPARTMENT OF THE TREASURY Internal Revenue Service Internal Revenue Service 26 CFR Parts 1 and 31 26 CFR Part 57 [REG–118315–12] [REG–130074–11] RIN 1545–BL20 RIN 1545–BK54 Rules Relating to Additional Medicare Tax; Hearing Cancellation Internal Revenue Service (IRS), Treasury. AGENCY: Cancellation of notice of public hearing on proposed rulemaking. ACTION: This document cancels a public hearing on proposed regulations under sections 3101(b), 3102, 3202(a), 1401(b), 6205, and 6402 of the Internal Revenue Code; relating to the Additional Hospital Insurance Tax on income above threshold amounts as added by the Affordable Care Act. SUMMARY: The public hearing originally scheduled for April 4, 2013 at 10 a.m. is cancelled. DATES: FOR FURTHER INFORMATION CONTACT: Oluwafunmilayo Taylor of the Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration) at (202) 622–7180 (not a toll-free number). A notice of proposed rulemaking and a notice of public hearing that appeared in the Federal Register on Wednesday, December 5, 2012 (77 FR 72268) announced that a public hearing was scheduled for April 4, 2013, at 10 a.m. in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue NW., Washington, DC. The subject of the public hearing is under sections 3101(b), 3102, 3202(a), 1401(b), 6205, and 6402 of the Internal Revenue Code. The public comment period for these regulations expired on March 5, 2013. The notice of proposed rulemaking and notice of public hearing instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be addressed. As of Monday, March 18, 2013, no one has requested to speak. Therefore, the public hearing scheduled for April 4, 2013, is cancelled. SUPPLEMENTARY INFORMATION: Health Insurance Providers Fee; Correction Internal Revenue Service (IRS), Treasury. ACTION: Correction to notice of proposed rulemaking and notice of public hearing. AGENCY: SUMMARY: This document contains a correction to a notice of proposed rulemaking and notice of public hearing (REG–118315–12) that was published in the Federal Register on Monday, March 4, 2013 (78 FR 14034). The proposed regulations provide guidance on the annual fee imposed on covered entities engaged in the business of providing health insurance for United States health risks. FOR FURTHER INFORMATION CONTACT: Charles J. Langley, Jr. at (202) 622–3130 (not a toll free number). SUPPLEMENTARY INFORMATION: Background The notice of proposed rulemaking and notice of public hearing (REG– 118315–12) that is the subject of this correction is under Section 9010 of the Patient Protection and Affordable Care Act. Need for Correction As published, the notice of proposed rulemaking and notice of public hearing (REG–118315–12) contains an error that may prove to be misleading and is in need of clarification. Correction of Publication Accordingly, the notice of proposed rulemaking and notice of public hearing (REG–118315–12), that was the subject of FR Doc. 2013–04836, is corrected as follows: § 57.1 [Corrected] On page 14042, column 1, line 17 of paragraph (b), the language ‘‘section 9010 of the ACA, as amended.’’ is corrected to read ‘‘section 9010 of the ACA.’’. LaNita VanDyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration). [FR Doc. 2013–06557 Filed 3–21–13; 8:45 am] 16:48 Mar 21, 2013 Jkt 229001 [FR Doc. 2013–06701 Filed 3–21–13; 8:45 am] BILLING CODE 4830–01–P VerDate Mar<15>2010 LaNita VanDyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). BILLING CODE 4830–01–P PO 00000 Frm 00007 Fmt 4702 Sfmt 9990 E:\FR\FM\22MRP1.SGM 22MRP1

Agencies

[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Proposed Rules]
[Pages 17611-17612]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part Chapter 1

[Docket No. FDA-2013-N-0260]


Provisions of the Food and Drug Administration Safety and 
Innovation Act Related to Medical Gases; Request for Comments Regarding 
Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is inviting comments 
from the public on whether any potential changes to the Federal drug 
regulations are necessary for medical gases.

DATES: Submit electronic or written comments by May 21, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 
Christine Kirk, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6280, Silver 
Spring, MD 20993-0002, 301-796-2465, christine.kirk@fda.hhs.gov; or
Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and 
Drug Administration, 7500 Standish Pl., MPN2, Rockville, MD 20855, 240-
276-8331, germaine.connolly@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, President Obama signed the Food and Drug Safety 
and Innovation Act (FDASIA) (Pub. L. 112-144) into law. Section 1112(a) 
of FDASIA provides that not later than 18 months after its enactment, 
the Secretary of Health and Human Services, after obtaining input from 
medical gas manufacturers and any other interested members of the 
public, shall determine whether any changes to the Federal drug 
regulations are necessary for medical gases and submit a report 
regarding any such changes to the Committee on Health, Education, 
Labor, and Pensions of the U.S. Senate and the Committee on Energy and 
Commerce of the U.S. House of Representatives. Section 1112(c)(l) 
defines ``Federal drug regulations'' to mean ``regulations in title 21 
of the Code of Federal Regulations pertaining to drugs.''
    Section 1112(b) provides that if the Secretary determines that 
changes to the Federal drug regulations are necessary for medical 
gases, the Secretary shall issue final regulations revising the Federal 
drug regulations with respect to medical gases not later than 48 months 
after the enactment of FDASIA. FDA is opening this docket to provide 
the public with an opportunity to submit comments on whether any 
potential changes to Federal drug regulations are necessary for medical 
gases.

II. Opportunities for Comment on Other Medical Gas Dockets

    FDASIA also added new sections regarding medical gases to the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (see Title XI, 
Subtitle B, section 1111 of FDASIA, adding new sections 575, 576, and 
577 to the FD&C Act). FDA has previously issued two other Federal 
Register notices related to these new sections.
    On November 23, 2012 (77 FR 70166), FDA issued a Federal Register 
notice

[[Page 17612]]

establishing a public docket (Docket No. FDA-2012-N-1090) for 
information pertaining to FDA's implementation of the provisions of 
FDASIA related to medical gases. Interested persons may submit comments 
relevant to that Federal Register notice (see ADDRESSES) under Docket 
No. FDA-2012-N-1090.
    On December 18, 2012 (77 FR 74852), FDA issued a notice of 
availability announcing publication of a draft guidance for industry 
entitled ``Certification Process for Designated Medical Gases'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332136.pdf) (Docket No. FDA-2012-D-1197). The draft 
guidance describes the new certification process created by FDASIA for 
certain medical gases and explains how FDA plans to implement that 
process. Interested persons may submit comments regarding the draft 
guidance (see ADDRESSES) under Docket No. FDA-2012-D-1197. Please note 
that although comments on draft guidance may be submitted at any time, 
FDA requested that comments be submitted by February 19, 2013, in order 
to allow adequate time for the comments to be considered while the 
Agency is preparing final guidance.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06526 Filed 3-21-13; 8:45 am]
BILLING CODE 4160-01-P