Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension of Comment Period, 57892-57893 [E6-16208]

Download as PDF 57892 Proposed Rules Federal Register Vol. 71, No. 190 Monday, October 2, 2006 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 40 [Docket Nos. RM06–16–000 and RM06–22– 000] Mandatory Reliability Standards for the Bulk Power System Issued September 18, 2006. Federal Energy Regulatory Commission, DOE. ACTION: Notice announcing rulemaking process. AGENCY: The Federal Energy Regulatory Commission (Commission) is announcing a rulemaking process for mandatory Reliability Standards for the Bulk-Power System and specifically, its inclusion of certain Reliability Standards proposed by the North American Electric Reliability Council (NERC) in the Commission’s upcoming Notice of Proposed Rulemaking which will be issued in Docket No. RM06–16– 000. The Commission will also open a new proceeding in Docket No. RM06– 22–000, which will process additional Reliability Standards proposed by NERC. SUMMARY: mstockstill on PROD1PC61 with PROPOSALS FOR FURTHER INFORMATION CONTACT: Jonathan First, Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426; (202) 502–8529. SUPPLEMENTARY INFORMATION: On August 28, 2006, the North American Electric Reliability Council, on behalf of its affiliate, the North American Electric Reliability Corporation (NERC Corporation, and collectively NERC), filed 27 proposed Reliability Standards for Commission approval. The Commission certified NERC Corporation as the Electric Reliability Organization (ERO) pursuant to section 215 of the Federal Power Act (FPA) in an order issued July 20, 2006 in Docket No. RR06–1–000. VerDate Aug<31>2005 15:35 Sep 29, 2006 Jkt 211001 NERC requested that these 27 proposed Reliability Standards be included in the upcoming Notice of Proposed Rulemaking (NOPR) in Docket No. RM06–16–000. Because of their close relationship with Reliability Standards already filed in that docket, the Commission will address 19 of the 27 proposed Reliability Standards in the upcoming NOPR in Docket No. RM06– 16–000. The 19 Reliability Standards to be addressed in this docket are: INT–001–1—Interchange Information INT–003–1—Interchange Transaction Implementation INT–004–1—Dynamic Interchange Transaction Modifications INT–005–1—Interchange Authority Distributes Arranged Interchange INT–006–1—Response to Interchange Authority INT–007–1—Interchange Confirmation INT–008–1—Interchange Authority Distributes Status INT–009–1—Implementation of Interchange INT–010–1—Interchange Coordination Exemptions EOP–005–1—System Restoration Plans MOD–013–1—Dynamics Data Requirements and Reporting Procedures MOD–016–1—Actual and Forecast Demands, Net Energy for Load, Controllable DSM PRC–002–1—Define Regional Disturbance Monitoring and Reporting Requirements PRC–018–1—Disturbance Monitoring Equipment Installation and Data Reporting VAR–001–1—Voltage and Reactive Control VAR–002–1—Generator Operation for Maintaining Network Voltage Schedules TOP–002–1—Normal Operations Planning IRO–006–3—Reliability Coordination— Transmission Loading Relief BAL–006–1—Inadvertent Interchange The Commission is also opening a new Docket No. RM06–22–000 for processing the remaining 8 proposed Reliability Standards. No preliminary comments are being sought at this time. A proposed rulemaking will be issued later, and we will allow comments then. The 8 Reliability Standards included in this docket are: CIP–002–1—Cyber Security—Critical Cyber Asset Identification CIP–003–1—Cyber Security—Security Management Controls CIP–004–1—Cyber Security—Personnel and Training CIP–005–1—Cyber Security—Electronic Security Perimeter(s) CIP–006–1—Cyber Security—Physical Security of Critical Cyber Assets CIP–007–1—Cyber Security—Systems Security Management CIP–008–1—Cyber Security—Incident Reporting and Response Planning PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 CIP–009–1—Cyber Security—Recovery Plans for Critical Cyber Assets This filing is accessible on-line at https://www.ferc.gov, using the ‘‘eLibrary’’ link and is available for review in the Commission’s Public Reference Room in Washington, DC. There is an ‘‘eSubscription’’ link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail FERCOnlineSupport@ferc.gov, or call (866) 208–3676 (toll free). For TTY, call (202) 502–8659. Magalie R. Salas, Secretary. [FR Doc. E6–15797 Filed 9–29–06; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 20, 25, 201, 202, 207, 225, 226, 500, 510, 511, 515, 516, 558, and 589 [Docket No. 2006N–0067] RIN 0910–AF67 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment period. ACTION: SUMMARY: The Food and Drug Administration (FDA) is extending to December 20, 2006, the comment period for the proposed rule that appeared in the Federal Register of August 22, 2006 (71 FR 48840). In the proposed rule, FDA requested comments on implementing regulations for the Federal Food, Drug, and Cosmetic Act (the act) entitled ‘‘Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.’’ The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written or electronic comments on the proposed rule by December 20, 2006. Submit comments E:\FR\FM\02OCP1.SGM 02OCP1 Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Proposed Rules regarding information collection by December 20, 2006, to the Office of Management and Budget (OMB) (see ADDRESSES). You may submit comments, identified by [Docket No. 2006N–0067 and RIN number 0910–AF67], by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: https:// www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301–827–6870. • Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions]: Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by email. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the Electronic Submissions portion of this paragraph. Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to https:// www.fda.gov/ohrms/dockets/ default.htm, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.fda.gov/ohrms/dockets/ default.htm and insert the docket number(s), found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Information Collection Provisions: Submit written comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB).To ensure that comments mstockstill on PROD1PC61 with PROPOSALS ADDRESSES: VerDate Aug<31>2005 15:35 Sep 29, 2006 Jkt 211001 on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. DEPARTMENT OF HOMELAND SECURITY FOR FURTHER INFORMATION CONTACT: 57893 [CGD01–05–094] Bernadette Dunham, Center for Veterinary Medicine (HFV–50), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276– 9090, e-mail: Bernadette.Dunham@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of August 22, 2006, FDA published a proposed rule with a 90-day comment period to request comments on implementing regulations for the indexing provisions of the Minor Use and Minor Species Animal Health Act of 2004. Comments on the proposed rule will inform FDA’s rulemaking to establish regulations for the procedures and criteria for index listing a new animal drug for use in a minor species. The agency has received requests for a 30-day extension of the comment period for the proposed rule. Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the requests and is extending the comment period for the proposed rule for 30 days, until December 20, 2006. The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–16208 Filed 9–29–06; 8:45 am] BILLING CODE 4160–01–S Frm 00002 Fmt 4702 33 CFR Part 165 RIN 1625–AA11 Regulated Navigation Area: Navigable Waters Within Narragansett Bay, RI and Mount Hope Bay, MA, Including the Providence River and Taunton River Coast Guard, DHS. Notice of public meetings, and re-opening of comment period. AGENCY: I. Background PO 00000 Coast Guard Sfmt 4702 ACTION: SUMMARY: In response to public requests, the Coast Guard will hold two public meetings to receive comments on its Notice of Proposed Rulemaking (NPRM) to modify the existing Regulated Navigation Area (RNA) in the Providence River, Narragansett Bay, and Mount Hope Bay. Additionally, the Coast Guard is re-opening the period to receive comments on that NPRM. Holding two public meetings and reopening the comment period will provide the public additional opportunities and more time to submit comments and recommendations. DATES: A public meeting will be held in Fall River, MA, on October 16, 2006, beginning at 7 p.m., and in Warwick, RI, on October 19, 2006, beginning at 7 p.m. Comments and related material must reach the Coast Guard on or before November 1, 2006. ADDRESSES: You may mail comments and related material to U.S. Coast Guard Sector Southeastern New England, Prevention Department, 20 Risho Avenue, East Providence, RI 02914– 1208. U.S. Coast Guard Sector Southeastern New England maintains the public docket for this rulemaking. Comments and documents will become part of this docket and will be available for inspection and copying at the same address between 8 a.m. and 3 p.m. Monday through Friday, except Federal holidays. The public meetings locations are: • Bristol Community College, Margaret Jackson Arts Center Theater, 777 Elsbree Street, Fall River, Massachusetts; and • Community College of Rhode Island, Knight Campus, Henderson Presentation Room #4080, 400 East Avenue, Warwick, Rhode Island. FOR FURTHER INFORMATION CONTACT: Mr. Edward G. LeBlanc at Coast Guard Sector Southeastern New England, 401– 435–2351. E:\FR\FM\02OCP1.SGM 02OCP1

Agencies

[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Proposed Rules]
[Pages 57892-57893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16208]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 25, 201, 202, 207, 225, 226, 500, 510, 511, 515, 
516, 558, and 589

[Docket No. 2006N-0067]
RIN 0910-AF67


Index of Legally Marketed Unapproved New Animal Drugs for Minor 
Species; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending to 
December 20, 2006, the comment period for the proposed rule that 
appeared in the Federal Register of August 22, 2006 (71 FR 48840). In 
the proposed rule, FDA requested comments on implementing regulations 
for the Federal Food, Drug, and Cosmetic Act (the act) entitled ``Index 
of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' 
The agency is taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit written or electronic comments on the proposed rule by 
December 20, 2006. Submit comments

[[Page 57893]]

regarding information collection by December 20, 2006, to the Office of 
Management and Budget (OMB) (see ADDRESSES).

ADDRESSES:  You may submit comments, identified by [Docket No. 2006N-
0067 and RIN number 0910-AF67], by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to https://www.fda.gov/ohrms/dockets/
default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB).To ensure 
that comments on the information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Bernadette Dunham, Center for 
Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail: 
Bernadette.Dunham@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 22, 2006, FDA published a 
proposed rule with a 90-day comment period to request comments on 
implementing regulations for the indexing provisions of the Minor Use 
and Minor Species Animal Health Act of 2004. Comments on the proposed 
rule will inform FDA's rulemaking to establish regulations for the 
procedures and criteria for index listing a new animal drug for use in 
a minor species.
    The agency has received requests for a 30-day extension of the 
comment period for the proposed rule. Each request conveyed concern 
that the current 90-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 30 days, until December 20, 2006. The agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this document. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16208 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S

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