Federal Register - October 1, 1957
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Source: Federal Register
UTTERA
SCRIPTA
FEDERAL
VOLUME 22
REGISTER
NUMBER 190
Washington, Tuesday, October 1, 1957
TITLE 9 ANIM ALS AN D
ANIM AL PRODUCTS
Chapter I-Agricultural R e s e a r c h Service, Department of Agriculture Subchapter E Viruses, Serums, Toxins, and Analogous Products; Organisms and Vector P art
101 G e n e r a l P r o v is io n s
P art
112 L a b e ls
Part
and
S am ples
114 M is c e l l a n e o u s R e q u ir e m e n t s for
P art Part
L ic e n s e d E s t a b l is h m e n t s
116 R ecords
and
R ep o r t s
119 A n t i - H o g - C h o l e r a S e r u m m is c e l l a n e o u s a m e n d m e n t s
Pursuant to the virus-serum-toxin provisions of the act of March 4,1913 21
U. S. C. 151-158, Parts 101,112,114,116, and 119 of the regulations relating to viruses, serums, toxins, and analogous products, organisms, and vectors in 9
CFR Parts 101, 112, 114, 116, and 119, as amended, are hereby further amended as follows:
1. Section 101.1 aa is amended to read:
4. Section 116.1 is amended to read:
116.1 Maintenance of records. De tailed records of the results of tests for purity and potency and of the methods of preservation of each batch of bio logical products shall be kept by each licensee. Biological products prepared in foreign countries shall be eligible for importation into the United States only if the foreign manufacturer of such products also maintains such records.
Detailed records in form satisfactory to the Director shall be maintained by each licensee, each distributor, and each im porter, showing the sale, shipment, or other disposition made of the biological products handled by such person.
5. Section 116.2 b read:
is amended to
b Other records. 1 Licensees shall maintain production records in ink or the equivalent. These records shall in clude a record of all pigs used to pro duce hog-cholera virus. The informa tion on the production record shall be substantially the same as that shown on the work sheets as provided in para graph a of this section, and in addition aa Anti-hog-cholera serum.
T h e x it shall include the date on which each clear serum, plasma, or other derivatives pig ws killed and the serial number of of hyperimmune blood, containing the the batch of virus produced. Such rec protective substances, derived from im ords shall contain information as to the mune hogs which have been hyperimtotal quantity in each batch of hypermunized by intravenous injection with immunizing, simultaneous, or inoculat hog-cholera virus, or antibodies concen ing virus produced. All such records trated therefrom. Such concentrated shall clearly show the particular animal antibodies are referred to as hog-cholera or group of animals from which each batch of the product is derived. The antibody-concentrate.
quantity of product collected and the 2. Section 112.2 is amended by adding total quantity of product after phenolithereto a new paragraph d to read:
zation shall be separately recorded.
2 Records showing the hyperim d Anti-hog-cholera serum consistm? of concentrated anitbodies shall be munization o f immune hogs and the named hog-cholera antibody-concen bleeding of hyperimmune hogs shall be trate.
maintained.
3 Charts of the automatic tempera 3. Section 114.2 b Is amended by ture-recording thermometers used in changing the second sentence therein connection with the heating and cooling w> read: An outline with respect to of anti-hog-cholera serum shall be filed hog-cholera virus for inoculating pur as a part of the Division station records.
poses shall also be submitted to the Di 4 Complete records of the prepara vision in accordance with 118.3 of this tion and mixing of all virus and serum subchapter, and an outline with respect into batches and the bottling, testing, to hog-cholera antibody-concentrate and labeling thereof shall be maintained.
may be submitted to the Division in ac . 5 Work sheets prepared like those cordance with 119.2 b of this sub used by Inspectors will be deemed to chapter.
Continued on next page
CONTENTS
Agricultural Marketing Service Proposed rule making:
Potatoes grown in certain desig nated Counties in Idaho and Malheur County, Oreg_______
Rules and regulations:
Christmas trees; United States standards_________ ________ _
Milk; in Platte Valley, Nebr., marketing area_____________
Page
7771
7767
7768
Agricultural Research Service Rules and regulations:
Viruses, serums, toxins and analogous products; organ isms and vectors; miscellane ous amendments___________ _
7765
Agriculture Department See Agricultural Marketing Serv ice; Agricultural Research Serv ice.
Army Department See Engineers Corps.
Civil Service Commission Rules and regulations:
Exceptions from competitive service:
Housing and Home Finance Agency______ ______________
National Security Training Commission_______________
7767
7767
Commerce Department Notices:
Statements of change in finan cial interests:
Harding, George E________ ,__
McCarthy, Vern L., Jr_______
Oheim, Curt L _____________ _
7777
7777
7777
Defense Department See also Engineers Corps.
Rules and regulations:
Transportation of household goods of uniformed personnel by motor van carriers; mis cellaneous amendments_____
7769
Engineers Corps Rules and regulations:
Anchorage; Connecticut River, Conn______________ ______ _
7769
Federal Communications Com mission Notices:
Hearings, etc.:
Gaines, Walter T. W G AV
7765
7776