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Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations 8547

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Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations 8547 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations 8547 Dated: February 3, 1995. removes 21 CFR 558.625(b)(11) and attends a United States accredited post- Fred R. Shank, (b)(15) and amends 21 CFR secondary educational institution. Director, Center for Food Safety and Applied 558.635(b)(2) to reflect the withdrawal These rules are promulgated pursuant to Nutrition. of approval of these NADA's. Public Law 103±415 which authorizes the continued operation, until [FR Doc. 95±3804 Filed 2±14±95; 8:45 am] List of Subjects in 21 CFR Part 558 BILLING CODE 4160±01±F September 30, 1995, of au pair programs Animal drugs, Animal feeds. currently designated by the Agency. Therefore, under the Federal Food, DATES: Effective date: These rules are 21 CFR Part 558 Drug, and Cosmetic Act and under effective February 15, 1995. authority delegated to the Commissioner Applicability dates: With the New Animal Drugs for Use in Animal of Food and Drugs and redelegated to exceptions of § 514.31(j) (1) and (4), and Feeds; Tylosin and Virginiamycin the Center for Veterinary Medicine, 21 § 514.31(k), these rules apply to all au CFR part 558 is amended as follows: AGENCY: Food and Drug Administration, pair placements and operations as of HHS. February 15, 1995. The provisions set PART 558ÐNEW ANIMAL DRUGS FOR forth at § 514.31(j) (1) and (4) and ACTION: Final rule. USE IN ANIMAL FEEDS § 514.31(k) shall apply only to au pair SUMMARY: The Food and Drug 1. The authority citation for 21 CFR participants placed after date of Administration (FDA) is amending the part 558 continues to read as follows: publication. animal drug regulations to remove those Authority: Secs. 512, 701 of the Federal Compliance date: Sponsor portions reflecting approval of four new Food, Drug, and Cosmetic Act (21 U.S.C. implementation of the provisions set animal drug applications (NADA's) held 360b, 371). forth at § 514.31(g) (1) and (2) will not be expected before March 31, 1995. by Premiere Agri Technologies, Inc. The § 558.625 [Amended] NADA's provide for use of Type A FOR FURTHER INFORMATION CONTACT: 2. Section 558.625 Tylosin is medicated articles and Type B Stanley S. Colvin, Assistant General amended by removing and reserving medicated feeds containing tylosin and Counsel, United States Information paragraphs (b)(11) and (b)(15). Agency, 301 4th Street, SW., Type B medicated feeds containing 3. Section 558.635 Virginiamycin is virginiamycin. In a notice published Washington, DC 20547; Telephone, amended by revising paragraph (b)(2) to (202) 619±6829. elsewhere in this issue of the Federal read as follows: Register, FDA is withdrawing approval SUPPLEMENTARY INFORMATION: First of the NADA's. § 558.635 Virginiamycin begun pursuant to the provisions of the EFFECTIVE DATE: February 27, 1995. * * * * * United States Information and Educational Exchange Act of 1948 FOR FURTHER INFORMATION CONTACT: (b) * * * (``Smith-Mundt''), and subsequently Mohammad I. Sharar, Center for (2) 2.2 percent activity (10 grams per incorporated into and broadened under Veterinary Medicine (HFV±216), Food pound) to 011490, 016968, and 017790 the Fulbright-Hays Act, educational and and Drug Administration, 7500 Standish in § 510.600(c) of this chapter for use as cultural exchange activities have, over Pl., Rockville, MD 20855, 301±594± in paragraphs (f)(1)(iv) and (f)(1)(v) of the past forty years, exposed millions of 1722. this section. foreign nationals to the United States, * * * * * SUPPLEMENTARY INFORMATION: In a notice its peoples, cultures, skills, business published elsewhere in this issue of the Dated: January 6, 1995. techniques, educational institutions, Federal Register, FDA is withdrawing Stephen F. Sundlof, and way of life. The Fulbright-Hays Act approval of the following NADA's: Director, Center for Veterinary Medicine. mandates reciprocal exchange and [FR Doc. 95±3802 Filed 2±14±95; 8:45 am] Americans traveling abroad have, in NADA Sponsor name No. Drug name and address BILLING CODE 4160±01±F similar fashion, developed an enhanced awareness of foreign people, their 45±690 . Tylosin Type B Premiere Agri cultures and societies. Thus, Fulbright- medicated Technologies, UNITED STATES INFORMATION Hays programs further one of the feeds and Inc., P.O. Box AGENCY Agency's primary missions: increasing Type A medi- 2508, Fort mutual understanding between cated article. Wayne, IN 22 CFR Part 514 Americans and others through people- 46801±2508 [Rulemaking No. 110] to-people contact. Originally conducted (former spon- by the Department of State, oversight of sor Henwood Exchange Visitor Program Feed Addi- exchange activities, occurring under the tives) AGENCY: United States Information umbrella of the Exchange Visitor 97±289 . Tylosin Type B Do. (Former Agency. Program, has been the responsibility of medicated sponsor Feed ACTION: Final rule. the Agency since 1978. feeds and Specialties The Fulbright-Hays Act sets forth Type A medi- Co., Inc.) SUMMARY: The Agency hereby adopts as certain parameters which all exchange cated article. final with modifications the interim rule activities must meet. With an eye 133±361 Virginiamycin Do. (Former governing its oversight and towards ensuring that these parameters Type B medi- sponsor Feed cated feed. Specialties administration of au pair programs. Au were being met and acting in response Co., Inc.) pair programs permit foreign nationals to a Congressional request, the General 133±839 Virginiamycin Do. (Former to enter the United States for a period Accounting Office (``GAO'') investigated Type B medi- sponsor Mac- of one year for the purpose of residing Agency oversight and administration of cated feed. Page, Inc.) with an American host family while the Exchange Visitor Program and its participating directly in the home life of attendant utilization of the J visa. In its The sponsor requested withdrawal of the family and providing limited child report to Congress, dated February 5, approval of the NADA's. This final rule care services. The foreign national also 1990 and entitled ``Inappropriate Uses 8548 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations of Educational and Cultural Exchange about Congressional and public scrutiny becomes primarily a child care program, Visas,'' the GAO determined that certain of these programs. This scrutiny, in no matter how valuable, it can be legally Exchange Visitor Program activities turn, resulted in Congressional action maintained as a federal program only if appeared to be inconsistent with the which authorized and directed the it is transferred to another agency. statutory grant of authority and its Agency to promulgate regulations Although a distinct small minority, underlying legislative intent. GAO governing au pair placements. some letters criticized the Agency for summarized its findings, stating: Pursuant to this clear directive, the virtually any effort to regulate the ``Most J visa activities appear to conform to Agency published, on December 14, program as undue interference into the intent of the 1961 act. However, GAO 1994, interim final regulations family activities. While the Agency has believes that certain activities and programs governing the au pair program that were made every effort to ensure that the in the trainee and international visitor both consistent with the provisions of regulations are as unburdensome as categories, including the summer student/ the Fulbright-Hays Act and which also possible, it is important to note that travel work, international camp counselor, provided safeguards for au pair certain regulations are necessary before and au pair (Child care) programs, are participants and the American host the Agency is legally permitted to inconsistent with the legislative intent. GAO families with whom they are placed. operate this program. Additionally, identified instances of participants working as waiters, cooks, child care providers, Given the wide popularity of these none of the regulations will affect amusement and leisure park workers, and programsÐand the criticisms of themÐ individuals involuntarily. The summer camp counselors. Authorizing J visas the Agency met with, solicited, and regulations apply only to families who for participants and activities that are not incorporated the views of the au pair voluntarily and deliberately choose to clearly for educational and cultural purposes organizations, interested members of the participate in the au pair program. as specified in the act dilute the integrity of public and the views of those In light of the comments it has the J visa and obscures the distinction congressional offices possessing received, the Agency has determined between the J visa and other visas granted for jurisdiction over educational and that the interim regulations published work purposes.'' cultural exchange programs. December 14, 1994 should be amended The concerns raised in the GAO The Agency's Federal Register as follows. report had troubled USIA for several publication of this interim rule with Educational Component years, especially the au pair program. request for public comment generated Objections to the operation of au pair over 3,000 responses from American As discussed above, the Agency's programs under the Exchange Visitor families during the thirty day public statutory authority to facilitate au pair Program and the use of the J visa were comment period. A considerable activities has been the subject of debate also raised by the Department of Labor, number of
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