Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction, 63361-63362 [E8-25471]

Download as PDF Federal Register / Vol. 73, No. 207 / Friday, October 24, 2008 / Rules and Regulations mstockstill on PROD1PC66 with RULES § 12.10 Service. (a) * * * (2) Filing with the Proceedings Clerk; proof of service. All documents which are required to be served upon a party shall be filed concurrently with the Proceedings Clerk, and shall meet the requirements as to form prescribed by §§ 12.11 and 12.12 of this part. Unless otherwise provided in these rules, a document shall be filed by: (i) Delivering it in person; (ii) Mailing it by first-class or a more expeditious form of United States mail, or delivering it to a similar commercial package delivery service; (iii) Transmitting the documents via facsimile machine (‘‘fax’’); or (iv) Via electronic mail (‘‘e-mail.’’) (v) Mailed documents must be addressed to: Proceedings Clerk, Office of Proceedings, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. Faxed documents should be sent to (202) 418– 5532 and e-mailed documents to (PROC_Filings@cftc.gov), directed to the Proceedings Clerk. Electronic filing and service in a given case shall be at the discretion of the Presiding Officer, with the parties’ consent. Signed documents that are served by e-mail attachment must be in PDF or other non-alterable form. To be timely filed under this part, a document must be delivered; mailed by first-class or a more expeditious form of United States mail or a similar commercial package delivery service; or faxed or e-mailed to the Proceedings Clerk within the time prescribed for filing. Proof of filing shall be made by attaching to the document to be filed an affidavit certifying that the attached document was either deposited in the mail or with the commercial package delivery service, with postage or delivery service fees prepaid, addressed to the Proceedings Clerk, Office of Proceedings, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581; or faxed or e-mailed to the Proceeding Clerk on the date specified in the affidavit. Proof of service of a document shall be made by filing with the Proceedings Clerk, simultaneously with the filing of the required document, an affidavit of service executed by any person 18 years of age or older or a certificate of service executed by an attorney-at-law qualified to practice before the Commission. The proof of service shall identify the persons served, state that service has been made, set forth the date of service, and recite the manner of service. (3) Service of orders and decisions. A copy of all notices, rulings, opinions, and orders of the Proceedings Clerk, the VerDate Aug<31>2005 15:58 Oct 23, 2008 Jkt 217001 Director of the Office of Proceedings, a Judgment Officer, Administrative Law Judge, the Deputy General Counsel for Opinions and Review or the Commission shall be served by the Proceedings Clerk on each of the parties. The Commission, in its discretion and with due consideration for the convenience of the parties, may serve the aforementioned documents to the parties by electronic means. (b) How service is made. (1) Service shall be made by: (i) Personal service; (ii) First-class or a more expeditious form of United States mail or a similar commercial package delivery service; (iii) Fax; or (iv) E-mail in accordance with the conditions set forth in paragraph (a)(2) of this section. (v) Service shall be complete at the time of personal service upon deposit in the mail or with a commercial package delivery service of a properly addressed document for which postage or delivery service fees have been prepaid; or upon transmission by fax or e-mail. Where service is effected by mail or a commercial package delivery service (but not by fax or e-mail), the time within which the person served may respond thereto shall be increased by five (5) days. Signed documents that are served by e-mail attachment must be in PDF or other non-alterable form. For the purposes of this Rule, service of any document by the Proceedings Clerk upon the Commission shall be regarded as service by mail. * * * * * 3. Section 12.11 is amended by revising paragraphs (a) and (c) to read as follows: ■ § 12.11 Formalities of filing of documents with the Proceedings Clerk. (a) Number of copies. Unless otherwise specifically provided, or unless filed by fax or e-mail in accordance with the requirements of § 12.10(a)(2), an original and one conformed copy of all documents shall be filed with the Proceedings Clerk. * * * * * (c) Format. All documents filed under the Reparation Rules shall be typewritten, printed, or, if a party is not represented by counsel, in plainly legible handwriting. Documents sent in hardcopy must be on good quality white paper, 81⁄2 by 111⁄2 inches and bound at the top only. Documents e-mailed in accordance with the requirements of § 12.10(a)(2) must be in PDF or other non-alterable form. All documents must be double-spaced, except for quotations PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 63361 more than 3 lines and footnotes, both of which should be single-spaced. * * * * * Issued in Washington, DC, on the 8th of October 2008, by the Commission. David A. Stawick, Secretary of the Commission. [FR Doc. E8–25354 Filed 10–23–08; 8:45 am] BILLING CODE 6351–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. FDA–2007–N–0379] (formerly Docket No. 2007N–0280) Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the ‘‘Analysis of Impacts’’ section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Diane Sullivan, Office of Policy (HF– 26), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–11, Rockville, MD 20857, 301–827–7069, email: diane.sullivan@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In FR Doc. E8–20709, appearing on page 51919 in the Federal Register of Monday, September 8, 2008, the following correction is made: 1. On page 51931, in the first column, under ‘‘IV. Analysis of Impacts,’’ in the first full paragraph, the sentence ‘‘The agency believes that this final rule is not a significant regulatory action as defined by the Executive order, because the rule either clarifies the agency’s longstanding interpretation of, or increases latitude for manufacturers in complying with, existing CGMP requirements’’ is corrected to read ‘‘The agency certifies that this final rule is not a significant regulatory action as defined by the Executive order, because the rule either clarifies the agency’s longstanding interpretation of, or increases latitude for manufacturers in complying with, existing CGMP requirements.’’ E:\FR\FM\24OCR1.SGM 24OCR1 63362 Federal Register / Vol. 73, No. 207 / Friday, October 24, 2008 / Rules and Regulations Dated: October 16, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–25471 Filed 10–23–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 505 [Docket No. FHWA–05–23393] RIN 2125–AF08 Projects of National and Regional Significance Evaluation and Rating Federal Highway Administration (FHWA), DOT. ACTION: Final rule. mstockstill on PROD1PC66 with RULES AGENCY: SUMMARY: Section 1301 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA–LU) (Pub. L. 109–59; 119 Stat. 1144) established a program to provide grants to States for Projects of National and Regional Significance (PNRS) to improve the safe, secure, and efficient movement of people and goods throughout the United States and to improve the health and welfare of the national economy. Section 1301 requires the Secretary of Transportation (Secretary) to establish regulations on the manner in which the proposed projects will be evaluated and rated, in order to determine which projects shall receive grant funding. This rule establishes the required evaluation and rating guidelines for proposed projects. Under this rule, a proposed project would be eligible for funding under the PNRS Program (Program) only if the Secretary finds that the project meets the eligibility requirements of the rule. The Secretary will then evaluate and rate each project as ‘‘highly recommended,’’ ‘‘recommended,’’ or ‘‘not recommended’’ based on the results of preliminary engineering, the project justification criteria, and the degree of non-Federal financial commitment. All funds authorized by section 1101(a)(15) of SAFETEA–LU for the Program are fully designated to the 25 projects listed in section 1301(m) of SAFETEA–LU. For the duration of SAFETEA–LU there are no additional funds available for distribution beyond those already designated, and there are no assurances that any additional funds will become available. Funding in future highway reauthorization bills is at the discretion of Congress. VerDate Aug<31>2005 15:58 Oct 23, 2008 Jkt 217001 to constructing PNRS would improve the safe, secure, and efficient movement of people and goods throughout the FOR FURTHER INFORMATION CONTACT: Mr. United States as well as improve the Edward Strocko, Office of Freight Management and Operations, HOFM–1, health and welfare of the national economy. (202) 366–2997, or Ms. Alla Shaw, Under these regulations, a State Office of the Chief Counsel, (202) 366– 1042, Federal Highway Administration, seeking a grant for a proposed PNRS would submit to the Secretary an 1200 New Jersey Avenue, SE., Washington, DC 20590. Office Hours are application that demonstrates the ability from 7:45 a.m. to 4:15 p.m., e.t., Monday of the proposed project to enhance the through Friday, except Federal holidays. national transportation system, generate national or regional economic benefits, SUPPLEMENTARY INFORMATION: reduce congestion, improve transportation safety, and attract nonElectronic Access and Filing You may retrieve a copy of the NPRM, Federal investment. The Secretary shall evaluate and rate comments submitted to the docket, and each proposed project as ‘‘highly a copy of this final rule online through recommended,’’ ‘‘recommended,’’ or the Federal eRulemaking portal at: ‘‘not recommended’’ based on the www.regulations.gov. The Web site is results of preliminary engineering, the available 24 hours each day, 365 days project criteria set forth in the each year. Electronic retrieval help and regulations, and degree of non-Federal guidelines are available under the help financial commitments. If the Secretary section of the Web site. finds that the proposed project meets An electronic copy of this document the requirements of the regulations, and may also be downloaded by accessing there is a reasonable likelihood that the the Office of the Federal Register’s home project will continue to meet such page at: https://www.archives.gov and the requirements, the Secretary may issue a Government Printing Office’s Web page letter of intent to obligate funds from at: https://www.gpoaccess.gov/nara. future available budget authority specified in law or execute a full Background funding grant agreement with a State. A Section 1301 of SAFETEA–LU full funding grant agreement (FFGA) establishes a program to finance critical, would establish the terms of Federal high-cost transportation infrastructure participation in the project, maximum facilities that address critical national amount of Federal financial assistance, economic and transportation needs. cover the period of time for completing These projects often involve multiple the project, and address the timely and levels of government, agencies, modes efficient management of the project in of transportation, and transportation accordance with applicable Federal goals and planning processes that are statutes, regulations, and policy, not easily addressed or funded within including oversight roles and existing surface transportation program responsibilities, and other terms and categories. Projects of National and conditions. Regional Significance would have The designated projects in section national and regional benefits, including 1301(m) of SAFETEA–LU are not improving economic productivity by subject to the criteria established in this facilitating international trade, relieving part, and the projects will not be subject congestion, and improving to the evaluation and rating as proposed transportation safety by facilitating in this part in order to receive the passenger and freight movement. SAFETEA–LU authorized funding. Additionally, this Program would However, projects currently designated further the goals of the Secretary’s under SAFETEA–LU section 1301(m) National Strategy to Reduce Congestion would be required to compete in the on America’s Transportation Network evaluation and rating process should 1 (Congestion Initiative). any new or additional funding be The benefits of PNRS would accrue authorized for this Program. beyond local areas and States, to the Nation as a whole. A program dedicated Notice of Proposed Rulemaking On July 24, 2006, FHWA published in 1 Speaking before the National Retail the Federal Register at 71 FR 41748 a Foundation’s annual conference on May 16, 2006, notice of proposed rulemaking (NPRM) in Washington, DC, U.S. Transportation Secretary to establish regulations on the manner Norman Mineta unveiled a new plan to reduce congestion plaguing America’s roads, rail and in which the proposed projects under airports. The National Strategy to Reduce the Projects of National and Regional Congestion on America’s Transportation Network Significance Program will be evaluated includes a number of initiatives designed to reduce and rated, in order to determine which transportation congestion and is available at the following URL: https://fightgridlocknow.com. projects shall receive grant funding. The Effective Date: This rule is effective November 24, 2008. DATES: PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\24OCR1.SGM 24OCR1

Agencies

[Federal Register Volume 73, Number 207 (Friday, October 24, 2008)]
[Rules and Regulations]
[Pages 63361-63362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210 and 211

[Docket No. FDA-2007-N-0379] (formerly Docket No. 2007N-0280)


Amendments to the Current Good Manufacturing Practice Regulations 
for Finished Pharmaceuticals; Final Rule; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of Monday, September 8, 2008 
(73 FR 51919). The final rule was published with an inadvertent error 
in the ``Analysis of Impacts'' section. This document corrects that 
error.

FOR FURTHER INFORMATION CONTACT: Diane Sullivan, Office of Policy (HF-
26), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-11, 
Rockville, MD 20857, 301-827-7069, e-mail: diane.sullivan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-20709, appearing on page 51919 
in the Federal Register of Monday, September 8, 2008, the following 
correction is made:
    1. On page 51931, in the first column, under ``IV. Analysis of 
Impacts,'' in the first full paragraph, the sentence ``The agency 
believes that this final rule is not a significant regulatory action as 
defined by the Executive order, because the rule either clarifies the 
agency's longstanding interpretation of, or increases latitude for 
manufacturers in complying with, existing CGMP requirements'' is 
corrected to read ``The agency certifies that this final rule is not a 
significant regulatory action as defined by the Executive order, 
because the rule either clarifies the agency's longstanding 
interpretation of, or increases latitude for manufacturers in complying 
with, existing CGMP requirements.''


[[Page 63362]]


    Dated: October 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25471 Filed 10-23-08; 8:45 am]
BILLING CODE 4160-01-S

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