Implantation or Injectable Dosage Form New Animal Drugs; Spectinomycin Sulfate, 31177-31178 [E7-10801]

Download as PDF Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / Rules and Regulations rmajette on PROD1PC64 with RULES pertain and no cause for suspension of the agreement exists’’ (19 CFR 12.104g(a)). On June 6, 2002, the former United States Customs Service published T.D. 02–30 in the Federal Register (67 FR 38877), which amended 19 CFR 12.104g(a) to reflect the extension of these import restrictions for an additional period of five years until June 9, 2007. After reviewing the findings and recommendations of the Cultural Property Advisory Committee, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, concluding that the cultural heritage of Peru continues to be in jeopardy from pillage of archaeological and certain ethnological materials, made the necessary determination to extend the import restrictions for an additional five years on April 26, 2007. Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions. The Designated List of Archaeological and Ethnological Material from Peru covered by these import restrictions is set forth in T.D. 97–50. The Designated List and accompanying image database may also be found at the following internet Web site address: https:// exchanges.state.gov/culprop/ pefact.html, by clicking ‘‘III. Categories of Artifacts Subject to Import Restriction’’, and Federal Register. A complete list is published in the Federal Register notice of June 11, 1997. It is noted that the materials identified in T.D. 97–50 as ‘‘certain pre-Colombian archaeological materials of Peru dating to the Colonial period and certain Colonial ethnological material from Peru’’ are referred to in the Determination to Extend as ‘‘Archaeological Material from the Prehispanic Cultures and Certain Ethnological Material from the Colonial Period of Peru.’’ The materials identified in T.D. 97–50 and those identified in the Determination to Extend are the same. The restrictions on the importation of these archaeological and ethnological materials from Peru are to continue in effect for an additional 5 years. Importation of such material continues to be restricted unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met. Inapplicability of Notice and Delayed Effective Date This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (5 U.S.C. 553(a)(1)). For the same reasons, pursuant to 5 VerDate Aug<31>2005 15:16 Jun 05, 2007 Jkt 211001 31177 U.S.C. 553(d)(3), a delayed effective date is not required. DEPARTMENT OF HEALTH AND HUMAN SERVICES Regulatory Flexibility Act Food and Drug Administration Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. Executive Order 12866 Because this rule involves a foreign affairs function of the United States, it is not subject to Executive Order 12866. Signing Authority This regulation is being issued in accordance with 19 CFR 0.1(a)(1). List of Subjects in 19 CFR Part 12 Cultural property, Customs duties and inspection, Imports, Prohibited merchandise. Amendment to CBP Regulations For the reasons set forth above, part 12 of Title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below: I PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The general authority citation for part 12 and the specific authority citation for § 12.104g continue to read as follows: I Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624; * * * * * Sections 12.104 through 12.104i also issued under 19 U.S.C. 2612; * * § 12.104g * * * [Amended] 2. In § 12.104g(a), the table of the list of agreements imposing import restrictions on described articles of cultural property of State Parties is amended in the entry for Peru by removing the reference to ‘‘T.D. 02–30’’ and adding in its place ‘‘CBP Dec. 07– 27’’ in the column headed ‘‘Decision No.’’. I Approved: June 1, 2007. Deborah J. Spero, Acting Commissioner, U.S. Customs and Border Protection. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. [FR Doc. 07–2810 Filed 6–5–07; 8:45 am] BILLING CODE 9111–14–P PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Spectinomycin Sulfate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for revising nomenclature for two bovine respiratory pathogens on labeling for spectinomycin sulfate injectable solution. DATES: This rule is effective June 6, 2007. Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Div. of Pfizer, Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 141–077 for ADSPEC (spectinomycin sulfate) Sterile Solution used for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for revising nomenclature for two bacterial pathogens on product labeling. The supplemental NADA is approved as of May 10, 2007, and the regulations in 21 CFR 522.2121 are amended to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\06JNR1.SGM 06JNR1 31178 Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / Rules and Regulations List of Subjects in 21 CFR Part 522 Animal drugs. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I 2. Revise § 522.2121 to read as follows: I Spectinomycin sulfate. (a) Specifications. Each milliliter of solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) spectinomycin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.600 of this chapter. (d) Conditions of use in cattle—(1) Amount. 10 to 15 mg per kilogram of body weight at 24-hour intervals for 3 to 5 consecutive days. (2) Indications for use. For the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. (3) Limitations. Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: May 24, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–10801 Filed 6–5–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF JUSTICE Bureau of Prisons 28 CFR Part 511 rmajette on PROD1PC64 with RULES [BOP–1128] RIN 1120–AB28 Searching and Detaining or Arresting Non-Inmates AGENCY: Bureau of Prisons, Justice. VerDate Aug<31>2005 15:16 Jun 05, 2007 Jkt 211001 Final rule. SUMMARY: In this document, the Bureau of Prisons (Bureau) finalizes regulations on searching and detaining or arresting non-inmates. This revision reorganizes current regulations and makes changes that subject non-inmates to pat searches, either as random searches or based upon reasonable suspicion, as a condition of entry to a Bureau facility. DATES: This rule is effective July 6, 2007. FOR FURTHER INFORMATION CONTACT: Authority: 21 U.S.C. 360b. § 522.2121 ACTION: Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone (202) 307–2105. SUPPLEMENTARY INFORMATION: In this document, the Bureau finalizes regulations on searching and detaining or arresting non-inmates. A proposed rule on this subject was published in the Federal Register on January 31, 2006 (71 FR 5026). We received four comments during the comment period. One was supportive of the rule. We respond to issues raised by the other three commenters below. Comment: Bureau staff should receive equivalent testing/scanning as the regulation requires for visitors. Two commenters expressed the opinion that Bureau staff should be subject to the same potential searches required for others seeking to enter Bureau facilities. In fact, Bureau employees are subject to search using the same search devices, methods, and technology employed to search other non-inmates seeking to enter Bureau facilities. Current Bureau policy regarding searching non-inmates states that, in accord with Bureau standards of employee conduct, the Bureau retains the right to conduct searches of employees when such a search is believed necessary to ensure institution security and good order. Also, at the beginning of their employment, every Bureau employee receives, and signs for, a copy of the Bureau’s Program Statement on Standards of Employee Conduct and Responsibility. This policy, along with signs posted at the entrances to each Bureau facility, notifies employees that they may be subject to any of the types of searches described above. Further, policy states that an employee’s refusal to undergo a search (including test) procedure is a basis for disciplinary action, including removal. The range of disciplinary actions that might be taken against an employee determined to be using illegal drugs, or introducing drugs or other forms of contraband, includes dismissal and criminal prosecution. PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 Comment: There are problems with the Bureau’s use of ion spectrometers to perform searches. Two commenters raised issues surrounding the Bureau’s use of ion spectrometers. Essentially, both commenters raised issues regarding the accuracy of such devices with regard to detecting illegal substances. Bureau’s response: At the outset, we note that the use of an ion spectrometry device is not the sole method of searching non-inmates, and may not be applied to search all non-inmates entering Bureau facilities. As the regulation explains, many types of searches may be conducted, including electronic searches, visual searches, pat searches, and urine surveillance testing, all with the primary goal of ensuring the safety, security and good order of Bureau facilities by reducing the introduction of contraband. Ion spectrometry technology is designed to detect the presence of microscopic traces of illegal drugs on non-inmates and their clothing and belongings. Beginning in 1997, the Bureau conducted extensive testing of ion spectrometry technology to scan non-inmates for drugs as they enter Bureau facilities. Based on the results of this program, the Bureau concluded that using ion spectrometry devices contributed to reducing the amount of contraband on Bureau grounds. Ion spectrometry technology is grounded in the well-established scientific principles of mass spectrometry and gas chromatography. Ion spectrometry devices are a minimally invasive method for screening people, packages, and cargo for traces of illegal substances. Although capable of identifying trace illegal substances within approximately the 1– 5 nanogram range (one nanogram equals one billionth of a gram), the Bureau’s machines are calibrated to register positive readings only at levels greater than those which may be casually encountered, for example by handling contaminated currency, using a public telephone, or shaking hands. The manufacturer of the Bureau’s ion spectrometry devices claims a less than 1% rate of false positive results. We have found that delivery of illicit substances while visiting is a common method for such substances to be introduced into institutions. Such methods include non-inmates swallowing small balloons full of illicit substances before entering the facility, then excreting and delivering the contents once inside. When done by this method, the ion spectrometry device may indicate handling of the illicit substance, while a further visual search of the individual would fail to disclose E:\FR\FM\06JNR1.SGM 06JNR1

Agencies

[Federal Register Volume 72, Number 108 (Wednesday, June 6, 2007)]
[Rules and Regulations]
[Pages 31177-31178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10801]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Spectinomycin Sulfate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, 
Inc. The supplemental NADA provides for revising nomenclature for two 
bovine respiratory pathogens on labeling for spectinomycin sulfate 
injectable solution.

DATES: This rule is effective June 6, 2007.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Div. of Pfizer, 
Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 
141-077 for ADSPEC (spectinomycin sulfate) Sterile Solution used for 
the treatment of bovine respiratory disease associated with several 
bacterial pathogens. The supplemental NADA provides for revising 
nomenclature for two bacterial pathogens on product labeling. The 
supplemental NADA is approved as of May 10, 2007, and the regulations 
in 21 CFR 522.2121 are amended to reflect the approval and a current 
format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

[[Page 31178]]

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  522.2121 to read as follows:


Sec.  522.2121  Spectinomycin sulfate.

    (a) Specifications. Each milliliter of solution contains 
spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) 
spectinomycin.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.600 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. 10 to 15 mg per 
kilogram of body weight at 24-hour intervals for 3 to 5 consecutive 
days.
    (2) Indications for use. For the treatment of bovine respiratory 
disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni.
    (3) Limitations. Do not slaughter within 11 days of last treatment. 
Do not use in female dairy cattle 20 months of age or older. Use in 
this class of cattle may cause residues in milk. A withdrawal period 
has not been established for this product in preruminating calves. Do 
not use in calves to be processed for veal. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

    Dated: May 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-10801 Filed 6-5-07; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.