New Animal Drugs For Use in Animal Feeds; Oxytetracycline, 45874-45875 [E8-18129]

Download as PDF 45874 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Rules and Regulations failed to disclose its board policy on director attendance at the annual meeting of security holders on its Web site, it would need to do so in its proxy statement.102 Hence, companies must make sure that their disclosure controls and procedures are designed to address the disclosure of such information on their Web sites. On the other hand, disclosure controls and procedures do not apply to other disclosures of information on a company’s Web site. This means that the principal executive officer and principal financial officer will not be disclosing their conclusions regarding the effectiveness of any controls that a company may have in place regarding its Web site disclosure of information, other than those controls with respect to information that is posted as an alternative to being provided in an Exchange Act report. That said, other disclosures on a company’s Web site are subject to antifraud liability, and companies also need to consider whether such disclosures are in compliance with Regulation FD, the Securities Act, and the federal proxy rules, among others. rmajette on PRODPC74 with RULES D. Format of Information and Readability The nature of online information is increasingly interactive, not static. The inability to print a particular browser screen or presentation, particularly one designed for interactive viewing and not for reading outside the electronic context, is not inherently detrimental to its readability. We do not think it is necessary that information appearing on company Web sites satisfy a printerfriendly standard 103 unless our rules explicitly require it.104 For example, our 102 See Instruction to Item 407(b)(2) of Regulation S–K [17 CFR 229.407(b)(2)]. 103 See 1996 Electronics Release, supra note 25 at Section II.A.2. We use the term ‘‘printer-friendly’’ to describe a version of a web page that is formatted for printing. For example, if a web page includes advertising and navigation, those items may be removed to format the relevant content for printing on standard size paper. 104 For example, Exchange Act Rule 14a–16(c) [17 CFR 240.14a–16(c)] requires proxy materials to be presented in a format convenient for both reading online and printing in paper when delivered electronically. See the text accompanying note [97] supra. See Shareholder Choice Release, supra note 21, at n. 35: ‘‘We believe that requiring readable and printable formats is important so that shareholders have meaningful access to the proxy materials.’’ Similarly, proposed Rule 498 under the Securities Act would permit the obligation to deliver a statutory prospectus relating to a mutual fund to be satisfied by sending or giving a summary prospectus and providing the statutory prospectus online. If provided online, proposed Securities Act Rule 498(f)(2)(i) would require that the statutory prospectus be presented in a format that is ‘‘convenient for both reading online and printing on paper.’’ See Mutual Fund Summary Prospectus VerDate Aug<31>2005 15:21 Aug 06, 2008 Jkt 214001 notice and access model requires that electronically posted proxy materials be presented in a format ‘‘convenient for both reading online and printing on paper.’’ 105 Hence, all other information on a company’s Web site need not be made available in a format comparable to paper-based information.106 III. Request for Comment PART 271—INTERPRETIVE RELEASES RELATING TO THE INVESTMENT COMPANY ACT OF 1940 AND GENERAL RULES AND REGULATIONS THEREUNDER Part 271 is amended by adding Release No. IC–28351 and the release date of August 1, 2008, to the list of interpretive releases. I We invite interested parties to submit written comment on any other approaches or issues involved in facilitating the use of electronic media, including as a result of technological developments, to further the disclosure purposes of the federal securities laws. By the Commission. Dated: August 1, 2008. Florence E. Harmon, Acting Secretary. [FR Doc. E8–18148 Filed 8–6–08; 8:45 am] List of Subjects in 17 CFR Parts 241 and 271 DEPARTMENT OF HEALTH AND HUMAN SERVICES Securities. Food and Drug Administration Amendment of the Code of Federal Regulations For the reasons set out in the preamble, Title 17 Chapter II of the Code of Federal Regulations is amended as set forth below: I PART 241—INTERPRETIVE RELEASES RELATING TO THE SECURITIES EXCHANGE ACT OF 1934 AND GENERAL RULES AND REGULATIONS THEREUNDER Part 241 is amended by adding Release No. 34–58288 and the release date of August 1, 2008, to the list of interpretive releases. I Proposing Release, supra note 27, at Section II.B.3. and n. 113. 105 See Exchange Act Rule 14a–16(c); Internet Proxy Release, supra note 10, at n. 82. 106 See 1996 Electronics Release, supra note 25, at Section II.A.2. As we noted in the 2000 Electronics Release, if special software is required in order to view information aimed at investors that a company puts on its Web site, we believe the company should make a free, downloadable version of the software available on the Web site or the site should contain information on the location where the required software may be downloaded free of charge so that all investors can effectively access the information provided. In the case of interactive data, we have taken a different approach. We have proposed that companies that maintain Web sites post on their Web sites the same interactive data they file or furnish with certain Exchange Act reports and Securities Act registration statements. We have not proposed, however, that registrants also provide interactive data viewers (or information on how to obtain viewers) on their Web sites. Instead, we have determined to allow third parties to develop viewers, anticipating that these viewers will, over time, become more readily accessible at a little or no cost to investors. The Commission makes several interactive data viewers available through its Web site at http:// www.sec.gov/spotlight/xbrl/xbrlwebapp.shtml. See Interactive Data Proposing Releases, supra note 14, at Section II.A, and supra note 15. PO 00000 Frm 00022 BILLING CODE 8010–01–P Fmt 4700 Sfmt 4700 21 CFR Part 558 [Docket No. FDA–2008–N–0039] New Animal Drugs For Use in Animal Feeds; Oxytetracycline 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 Phibro Animal Health. The supplemental NADA provides for use of oxytetracycline dihydrate in Type C medicated feeds for the control of mortality in freshwater-reared salmonids due to coldwater disease and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease. DATES: This rule is effective August 7, 2008. FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660, filed a supplement to NADA 38–439 for TERRAMYCIN 200 for Fish (oxytetracycline dihydrate) Type A medicated article used for control of certain bacterial diseases in several species of fish and for skeletal marking of Pacific salmon. The supplement provides for use of oxytetracycline dihydrate in Type C medicated feeds for E:\FR\FM\07AUR1.SGM 07AUR1 45875 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Rules and Regulations the control of mortality in freshwaterreared salmonids due to coldwater disease associated with Flavobacterium psychrophilum and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare. The supplemental NADA is approved as of July 6, 2008, and the regulations are amended in 21 CFR 558.450 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 573(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc–2(c)), this supplemental approval qualifies for 7 Oxytetracycline amount * * * * BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2008–0470] RIN 1625–AA11 rmajette on PRODPC74 with RULES Regulated Navigation Area and Safety Zone, Chicago Sanitary and Ship Canal, Romeoville, IL Coast Guard, DHS. Temporary final rule. AGENCY: SUMMARY: The Coast Guard is revising the dates and is reinstating a temporary VerDate Aug<31>2005 * * 15:21 Aug 06, 2008 Jkt 214001 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. 2. In § 558.450, in the table in paragraph (d)(5)(v), in the ‘‘Limitations’’ column, remove ‘‘; do not administer when water temperature is below 9 °C (48.2 °F)’’; redesignate paragraph (d)(5)(vi) as paragraph (d)(5)(vii); and add new paragraph (d)(5)(vi) to read as follows: I § 558.450 * Oxytetracycline. * * (d) * * * (5) * * * * * Fmt 4700 Sponsor * * Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated feed. Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated feed. * Frm 00023 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS * * regulated navigation area and safety zone on the Chicago Sanitary and Ship Canal near Romeoville, IL. This regulated navigation area and safety zone places navigational and operational restrictions on all vessels transiting through the electrical dispersal barrier IIA. DATES: This rule is effective from September 03, 2008 to October 15, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG–2008– 0470 and are available online at www.regulations.gov. They are also available for inspection or copying at two locations: The Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the U.S. Coast Guard Sector Lake Michigan, 2420 South Lincoln Memorial PO 00000 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 558 is amended as follows: I Limitations 1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum. 2. Freshwater-reared Oncorhynchus mykiss: For control of mortality due to columnaris disease associated with Flavobacterium columnare. Dated: July 28, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–18129 Filed 8–6–08; 8:45 am] ACTION: List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Indications for use * (vi) 3.75 g/100 lb of fish/day years of exclusive marketing rights beginning on the date of approval because the new animal drug has been declared a designated new animal drug by FDA under section 573(a) of the act. The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA’s finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. 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. Sfmt 4700 * 066104 066104 * Drive, Milwaukee, Wisconsin 53207, between 8:30 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions regarding this rule call CDR Tim Cummins, Deputy Prevention Division, Ninth Coast Guard District, telephone 216–902–6045. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826. SUPPLEMENTARY INFORMATION: Regulatory Information On July 2, 2008 we published a Temporary Final Rule (73 FR 37810). This Temporary Final Rule revises dates and reinstates the Temporary Final Rule published on July 2, 2008. Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. This regulated navigation area and safety zone is being implemented to ensure continued safe E:\FR\FM\07AUR1.SGM 07AUR1

Agencies

[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Rules and Regulations]
[Pages 45874-45875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2008-N-0039]


New Animal Drugs For Use in Animal Feeds; Oxytetracycline

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 Phibro Animal Health. The supplemental NADA 
provides for use of oxytetracycline dihydrate in Type C medicated feeds 
for the control of mortality in freshwater-reared salmonids due to 
coldwater disease and for the control of mortality in freshwater-reared 
Oncorhynchus mykiss due to columnaris disease.

DATES: This rule is effective August 7, 2008.

FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d 
floor, Ridgefield Park, NJ 07660, filed a supplement to NADA 38-439 for 
TERRAMYCIN 200 for Fish (oxytetracycline dihydrate) Type A medicated 
article used for control of certain bacterial diseases in several 
species of fish and for skeletal marking of Pacific salmon. The 
supplement provides for use of oxytetracycline dihydrate in Type C 
medicated feeds for

[[Page 45875]]

the control of mortality in freshwater-reared salmonids due to 
coldwater disease associated with Flavobacterium psychrophilum and for 
the control of mortality in freshwater-reared Oncorhynchus mykiss due 
to columnaris disease associated with Flavobacterium columnare. The 
supplemental NADA is approved as of July 6, 2008, and the regulations 
are amended in 21 CFR 558.450 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 573(c) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360ccc-2(c)), this supplemental approval qualifies 
for 7 years of exclusive marketing rights beginning on the date of 
approval because the new animal drug has been declared a designated new 
animal drug by FDA under section 573(a) of the act.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday.
    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.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.450, in the table in paragraph (d)(5)(v), in the 
``Limitations'' column, remove ``; do not administer when water 
temperature is below 9 [deg]C (48.2 [deg]F)''; redesignate paragraph 
(d)(5)(vi) as paragraph (d)(5)(vii); and add new paragraph (d)(5)(vi) 
to read as follows:


Sec.  558.450  Oxytetracycline.

* * * * *
    (d) * * *
    (5) * * *

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline amount            Indications for use                     Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(vi) 3.75 g/100 lb of fish/  1. Freshwater-reared salmonids:     Administer in mixed ration for 10        066104
 day                          For control of mortality due to     d; do not liberate fish or
                              coldwater disease associated with   slaughter fish for food for 21 d
                              Flavobacterium psychrophilum.       following the last administration
                                                                  of medicated feed.
                             2. Freshwater-reared Oncorhynchus   Administer in mixed ration for 10        066104
                              mykiss: For control of mortality    d; do not liberate fish or
                              due to columnaris disease           slaughter fish for food for 21 d
                              associated with Flavobacterium      following the last administration
                              columnare.                          of medicated feed.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


    Dated: July 28, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18129 Filed 8-6-08; 8:45 am]
BILLING CODE 4160-01-S