Select not less than 30 dosage units, and proceed as follows for the dosage form designated. Assume that the concentration weight Container No.905 drug substance per weight of dosage unit is uniform. Calculate the acceptance value. Remove the contents of each capsule by a suitable means. Accurately weigh the emptied shells individually, and calculate for each capsule the net weight of its contents by subtracting the weight of the shell from the respective gross weight.
Then cut open the capsules by means of a suitable clean, dry cutting instrument such as scissors or a sharp open blade, and remove the contents by washing with a suitable solvent. Allow the occluded solvent to evaporate from the shells at room temperature over a period of about 30 minutes, taking precautions to avoid uptake or loss of moisture.
Weigh the individual shells, and calculate the net contents. If necessary, compute the equivalent volume after determining the density. Remove the contents of each container by a suitable means. Accurately weigh the emptied containers individually, and calculate for each container the net weight of its contents by subtracting the weight of the container from the respective gross weight. Apply the following criteria, unless otherwise specified in the individual monograph.
Unless otherwise specified in the individual monograph, L1 is If 1 unit is outside the range of The requirements are met if not more than 1 unit of the 30 is outside the range of Limit B if the average of the limits specified in the potency definition in the individual monograph is greater than If 2 or 3 dosage units are outside the range of To become effective, the amendments had to be approved by at least two-thirds of those growers voting, or by voters representing at least two-thirds of the volume of citrus represented by voters voting in the referendum.
Voters voting in the referendum favored all of the proposed amendments. The amendments favored by voters and included in this final order will: Authorize regulation of new varieties and hybrids of citrus fruit; authorize the regulation of intrastate shipments of fruit; revise the process for redistricting the production area; change the term of office and tenure requirements for Committee members; authorize mail balloting procedures for Committee membership nominations; increase the capacity of Container No.905 reserve funds; authorize pack and container requirements for domestic shipments and authorize different regulations for different markets; eliminate the use of separate acceptance statements in the nomination process; and require handlers to register with the Committee.
USDA also made such changes as were necessary to the order so that all of the order's provisions conform to the effectuated amendments. A conforming change was made to the title of 7 CFR part The amended marketing agreement was subsequently mailed to all citrus handlers in the production area for their approval.
The marketing agreement was approved by handlers representing more than 50 percent of the volume of citrus handled by all handlers during the representative period of August 1,through July 31, Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be unduly or disproportionately burdened.
Marketing orders and amendments thereto are unique in that they are normally brought about through group action of essentially small entities for their own benefit. According to the U. Census of Agriculture, the number of citrus growers in Florida was 6, Based on the number of citrus growers from the U. Census of Agriculture and the total acres used for citrus production from NASS, the average citrus farm size is Therefore, a majority of Florida citrus producers are considered small entities under SBA's standards.
Based on information submitted by industry, 21 handlers would be considered small entities under SBA's standards.
A majority of citrus handlers are considered large entities under SBA's standards. The production area regulated under the order covers the portion of the state of Florida which is bound by the Suwannee River, the Georgia Border, the Atlantic Ocean, and the Gulf of Mexico. Acreage devoted to citrus production in the regulated area has declined in recent years.
Since then, bearing acreage for oranges has decreased 28 percent. This action amends the order to: Authorize regulation of new varieties and hybrids of citrus fruit; authorize the regulation of intrastate shipments of fruit; revise the process for redistricting the production area; change the term of office and tenure requirements for Committee members; authorize mail balloting procedures for Committee membership nominations; increase the capacity of financial reserve funds; authorize pack and container requirements for domestic shipments and authorize different regulations for different markets; eliminate the use of separate acceptance statements in the nomination process; and require handlers to register with the Committee.
These amendments will streamline program operations, but are not expected to result in a significant change in industry production, handling or distribution activities. During the hearing held on April 24,interested persons were invited to present evidence on the probable regulatory and informational impact of the proposed amendments to the order on small businesses.
The evidence presented at the hearing shows that none of the proposed amendments would have any burdensome effects on small agricultural producers or firms. In discussing the impacts of the amendments on growers and handlers, record evidence indicates that the changes are expected to be positive because the administration of the programs Container No.905 be more efficient, and therefore more effective, in executing Committee duties and responsibilities.
USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. These amendments are designed to enhance the administration and functioning of the order for the benefit of the Florida citrus industry.
The Letter of Acceptance has no time or cost burden associated with it due to the fact that handlers simply sign the form upon accepting nomination to the Committee. As a result, the current number of hours associated with OMB No. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to government information and services, and for other purposes.
The amendments to the order contained herein have been reviewed under Executive Container No.905Civil Justice Reform. They are not intended to have retroactive effect. The amendments do not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this proposal.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section c 15 A of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition.
The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.
The findings and determinations hereinafter set forth are supplementary to the findings and determinations that were previously made in connection with the issuance of the marketing order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein. Upon Container No.905 basis of the evidence introduced at such hearing and the record thereof, it is found that:.
It is necessary and in the public interest to make these amendments to the order effective not later than one day after publication in the Federal Register. A later effective date would unnecessarily delay implementation of the amendments for the new crop year, which begins August 1, In view of the foregoing, it is hereby found and determined that good cause exists for making these amendments effective one day after publication in the Federal Registerand Container No.905 it would be contrary to the public interest to delay the effective date for 30 days after publication in the Federal Register Sec.
It is therefore ordered, That on and after the effective date hereof, all handling of oranges, grapefruit, tangerines, and pummelos grown in Florida shall be in conformity to, and in compliance with, the terms and conditions of the said order as hereby amended as follows:.
The provisions of the proposed marketing order amending the order contained in the Secretary's Decision issued on February 23,and published in the March 3,issue of the Federal Register 80 CFR will be and are the terms and provisions of this order amending the order and are set forth in full below. For the reasons set out in the preamble, 7 CFR part is amended as follows:. The authority citation for 7 CFR part continues to read as follows:.
Authority: 7 U. AWB - Air waybill. Select company for shipment. Tracking number:. Container number consists of four-letters owner code, six-digits serial number and a check digit.
For example, MSKU Owner code shows the company that owns the container; it is not necessary the company that does transportation. Checkdigit can be used to identify mistypes in the container number.
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