Oakshire Naturals LP; Filing of Food Additive Petition, 47118-47119 [2018-20217]

Download as PDF 47118 Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Proposed Rules (a) Comments Due Date We must receive comments by November 2, 2018. (b) Affected ADs None. (c) Applicability This AD applies to Weatherly Aircraft Company (Weatherly) Models 201, 201A, 201B, 201C, 620, 620A, 620B, 620B–TG, and 620TP airplanes, all serial numbers, certificated in any category. (d) Subject Joint Aircraft System Component (JASC)/ Air Transport Association (ATA) of America Code 5740, Wing Attach Hinge Fitting. (e) Unsafe Condition This AD was prompted by reports of cracks found on the center wing front spar lower hinge bracket. We are issuing this AD to detect and correct corrosion and cracks on the wing hinge brackets and pin assemblies. The unsafe condition, if not addressed, could result in failure of the wing front and rear spar lower hinge brackets and lead to inflight separation of the wing with consequent loss of control of the airplane. (f) Compliance Comply with this AD within the compliance times specified, unless already done. daltland on DSKBBV9HB2PROD with PROPOSALS (g) Detailed Inspection (1) Within 3 months after the effective date of this AD and thereafter at intervals not to exceed 5 years, inspect each center and outer wing spar and spar cap, wing hinge bracket, and hardware for corrosion and cracks by following paragraphs 7 through 22 under the Detailed Inspection section in Weatherly 201/620 Service Bulletin SB–201/620–18001, Revision C, dated May 21, 2018 (Weatherly SB–201/620–18001, Revision C), except this AD does not require you to contact Weatherly. (2) Serial numbers (S/N) 1155 and 1558 have already had the initial detailed inspection required by paragraph (g)(1) of this AD and only the 5-year repetitive detailed inspections are required for these airplanes. (3) If any corrosion or cracking is found during any of the inspections required in paragraph (g)(1) of this AD, before further flight, repair or replace any parts with corrosion and cracking as specified in paragraphs 7 through 13 under the Detailed Inspection section in Weatherly SB–201/620– 18001, Revision C. (h) Visual Inspection Within 12 months after the initial detailed inspection required in paragraph (g) of this AD and thereafter at intervals not to exceed 12 months, visually inspect each forward and rear wing hinge bracket attachment pins, bolts, removed caps, spacers, and hardware for corrosion by following paragraphs 4 through 7 under the Visual Inspection section in Weatherly SB–201/620–18001, Revision C. If any corrosion is found during any of the inspections required by this paragraph, before further flight, inspect VerDate Sep<11>2014 16:57 Sep 17, 2018 Jkt 244001 further, repair, and/or replace any parts with corrosion as specified in paragraphs 5 and 6 under the Visual Inspection section in Weatherly SB–201/620–18001, Revision C. You may perform a detailed inspection in accordance with paragraph (g) of this AD instead of any visual inspection required by paragraph (h) of this AD. (i) Alternative Methods of Compliance (AMOCs) (1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD. (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. (j) Related Information (1) For more information about this AD, contact Mike Lee, Aerospace Engineer, Los Angeles Aircraft Certification Office, FAA, 3960 Paramount Blvd., Suite 100, Lakewood, California, 90712; phone: (562) 627–5325; fax: (562) 627–5210; email: mike.s.lee@ faa.gov. (2) For service information identified in this AD, contact Weatherly Aircraft Company, 2034 West Potomac Avenue, Chicago, Illinois 60622–3152; telephone: (424) 772–1812; email: garybeck@cox.net. You may view this referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329–4148. Issued in Kansas City, Missouri, on September 7, 2018. Melvin J. Johnson, Aircraft Certification Service, Deputy Director, Policy and Innovation Division, AIR–601. [FR Doc. 2018–20002 Filed 9–17–18; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA–2018–F–3230] Oakshire Naturals LP; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notification of petition. The Food and Drug Administration (FDA or we) is SUMMARY: PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 announcing that we have filed a petition, submitted by Oakshire Naturals LP, proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories. DATES: The food additive petition was filed on July 16, 2018. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number found in brackets in the heading of this document into the ‘‘Search’’ box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1071. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice that we have filed a food additive petition (FAP 8A4821), submitted by Oakshire Naturals LP, 295 Thompson Road, P.O. Box 388, Kennett Square, PA 19348. The petition proposes to amend the food additive regulations in part 172 (21 CFR part 172) Food Additives Permitted for Direct Addition to Food for Human Consumption to provide for the safe use of vitamin D2 mushroom powder, produced by exposing homogenized edible mushrooms to ultraviolet light, as a nutrient supplement in: (1) Foods to which vitamin D2, vitamin D3, and vitamin D2 bakers yeast are currently allowed to be added under 21 CFR 184.1950, 172.379, 172.380, and 172.381 (excluding cheese and cheese products, foods represented for use as a sole source of nutrition for enteral feeding, infant formula, milk and milk products, and margarine); (2) fruit smoothies; (3) vegetable juices; (4) extruded vegetable snacks; (5) soups and soup mixes (except for those containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act); and (6) plant protein products as defined in 21 CFR 170.3(n)(33). The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(k) because the substance is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If E:\FR\FM\18SEP1.SGM 18SEP1 Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Proposed Rules FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection. product to the market dominant or competitive product list.1 The proposed rules reflect lessons learned through the Commission’s experiences with the existing regulations and current practice before the Commission. The proposed rules appear after the signature of this order in Attachment A. Dated: September 12, 2018. Leslie Kux, Associate Commissioner for Policy. II. Proposed Amendments Section 3641 of title 39 of the United States Code authorizes the Postal Service to conduct market tests of experimental products. In accordance with its specific authority to regulate market tests under 39 U.S.C. 3641 and its general authority under 39 U.S.C. 503 to promulgate regulations and establish procedures, the Commission codified existing 39 CFR part 3035 to establish procedures for conducting market tests of experimental products.2 The Commission establishes this proceeding to consider amendments to the existing market test regulations. The proposed amendments are discussed below. The first set of amendments intend to revise the method for calculating applicable revenue limitations for market tests appearing in existing §§ 3035.15 and 3035.16 to be consistent with the current level of precision used in calculating the annual limitation on the percentage change in rates for market dominant products (price cap). The second set of proposed amendments aim to clarify the process under existing § 3035.18 for adding a non-experimental product or price category based on an experimental product to the market dominant or competitive product list and to emphasize the necessity of receiving specific detailed information in those instances. [FR Doc. 2018–20217 Filed 9–17–18; 8:45 am] BILLING CODE 4164–01–P POSTAL REGULATORY COMMISSION 39 CFR Part 3035 [Docket No. RM2018–12; Order No. 4822] Market Tests Postal Regulatory Commission. Notice of proposed rulemaking. AGENCY: ACTION: The Commission is proposing revisions to its rules governing market tests of experimental products. This document informs the public of the docket’s initiation, invites public comment, and takes other administrative steps. DATES: Comments are due on or before October 18, 2018. ADDRESSES: Submit comments electronically via the Commission’s Filing Online system at https:// www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives. SUMMARY: FOR FURTHER INFORMATION CONTACT: David A. Trissell, General Counsel, at 202–789–6820. SUPPLEMENTARY INFORMATION: A. Market Test Revenue Limitations Unless the Commission grants an exemption, total revenues anticipated or in fact received by the Postal Service from an experimental product must not exceed $10 million in any year. 39 U.S.C. 3641(e)(1). Upon written application of the Postal Service, the Table of Contents I. Introduction II. Proposed Amendments III. Section-by-Section Analysis IV. Administrative Actions V. Ordering Paragraphs daltland on DSKBBV9HB2PROD with PROPOSALS I. Introduction Pursuant to 39 U.S.C. 503 and 3641, this order establishes a rulemaking docket that proposes amendments to the Commission’s regulations governing market tests of experimental products appearing in existing 39 CFR part 3035. The proposed amendments would revise regulations concerning market test revenue limitations and requests to add a non-experimental product or price category based on an experimental VerDate Sep<11>2014 16:57 Sep 17, 2018 Jkt 244001 1 Product lists categorize postal products as either market dominant or competitive. 39 CFR 3020.1(b). Each experimental product during a market test is identified on the applicable product list under the organizational group heading ‘‘Market Tests’’ in accordance with 39 U.S.C. 3641(b)(3) and existing §§ 3020.4(b)(2)(ii)(D) and 3020.4(b)(3)(ii)(D) of this chapter. The intent of existing § 3035.18 and the revisions proposed in this order apply only to a request to offer a proposed product or price category in non-experimental status, that is— subject to the applicable requirements of 39 U.S.C. 3622, 3633, or 3642, and the applicable regulations promulgated thereunder. 2 See Docket No. RM2013–5, Order Adopting Final Rules for Market Tests of Experimental Products, August 28, 2014 (Order No. 2173). PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 47119 Commission may exempt the market test from the $10 million revenue limitation if certain requirements are met. 39 U.S.C. 3641(e)(2). If the Commission grants an exemption, total revenues anticipated, or in fact received by, the Postal Service from a market test may not exceed $50 million in any year. Id. These amounts must be adjusted annually by the change in the Consumer Price Index for such year, as determined under the regulations of the Commission. 39 U.S.C. 3641(g). Existing § 3035.15(a) uses the Consumer Price Index—All Urban Customers (CPI–U index), as specified by §§ 3010.21(a) and 3010.22(a) of this chapter, to calculate these amounts. Existing § 3035.15(d) explains the method for calculating the $10 million revenue limitation on a fiscal year basis, as adjusted for the change in the CPI– U index ($10 Million Adjusted Limitation). Calculating the $10 Million Adjusted Limitation involves three steps. First, a simple average CPI–U index was calculated for Fiscal Year 2008 by summing the monthly CPI–U values from October 2007 through September 2008 and dividing the sum by 12. 39 CFR 3035.15(d); see 39 U.S.C. 3641(g). The result is a Base Average of 214.5. 39 CFR 3035.15(d). Second, a second simple average CPI–U index is calculated for each subsequent fiscal year by summing the 12 monthly CPI– U values for the previous fiscal year and dividing the sum by 12 to obtain a Recent Average. Id. Third, the revenue limitation for the current fiscal year is calculated by multiplying $10 million by the Recent Average divided by the Base Average of 214.5. Id. The result is the $10 Million Adjusted Limitation, rounded to the nearest dollar. Id. Existing § 3035.16(c) sets forth corresponding steps for calculating the $50 million revenue limitation, as adjusted for the change in the CPI–U index ($50 Million Adjusted Limitation). Under existing §§ 3035.15 and 3035.16, the Base Average for both the $10 Million and $50 Million Adjusted Limitations is calculated using one decimal place (214.5). In Order No. 303, the Commission amended the price cap rules appearing in §§ 3010.21 and 3010.22 of this chapter to calculate the CPI–U price cap using three decimal places instead of one.3 The Commission 3 Docket No. RM2009–8, Order Amending the Cap Calculation in the System of Ratemaking, September 22, 2009, at 1–2 (Order No. 303); see Docket No. RM2009–8, Notice of Proposed Rulemaking to Amend the Cap Calculation in the System of Ratemaking, July 10, 2009 (Order No. 246). E:\FR\FM\18SEP1.SGM 18SEP1

Agencies

[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Proposed Rules]
[Pages 47118-47119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20217]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2018-F-3230]


Oakshire Naturals LP; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Oakshire Naturals LP, 
proposing that the food additive regulations be amended to provide for 
the safe use of vitamin D2 mushroom powder as a nutrient 
supplement in specific food categories.

DATES: The food additive petition was filed on July 16, 2018.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this document into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1071.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 8A4821), submitted by 
Oakshire Naturals LP, 295 Thompson Road, P.O. Box 388, Kennett Square, 
PA 19348. The petition proposes to amend the food additive regulations 
in part 172 (21 CFR part 172) Food Additives Permitted for Direct 
Addition to Food for Human Consumption to provide for the safe use of 
vitamin D2 mushroom powder, produced by exposing homogenized 
edible mushrooms to ultraviolet light, as a nutrient supplement in: (1) 
Foods to which vitamin D2, vitamin D3, and 
vitamin D2 bakers yeast are currently allowed to be added 
under 21 CFR 184.1950, 172.379, 172.380, and 172.381 (excluding cheese 
and cheese products, foods represented for use as a sole source of 
nutrition for enteral feeding, infant formula, milk and milk products, 
and margarine); (2) fruit smoothies; (3) vegetable juices; (4) extruded 
vegetable snacks; (5) soups and soup mixes (except for those containing 
meat or poultry that are subject to regulation by the U.S. Department 
of Agriculture under the Federal Meat Inspection Act or the Poultry 
Products Inspection Act); and (6) plant protein products as defined in 
21 CFR 170.3(n)(33).
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(k) because the substance is intended to 
remain in food through ingestion by consumers and is not intended to 
replace macronutrients in food. In addition, the petitioner has stated 
that, to their knowledge, no extraordinary circumstances exist. If

[[Page 47119]]

FDA determines a categorical exclusion applies, neither an 
environmental assessment nor an environmental impact statement is 
required. If FDA determines a categorical exclusion does not apply, we 
will request an environmental assessment and make it available for 
public inspection.

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20217 Filed 9-17-18; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.