Port Access Route Study: The Approaches to San Francisco, 56919-56920 [2010-23176]

Download as PDF Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 5. Section 114.13 is revised to read as follows: ■ wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1 § 114.13 Determination of the expiration dating period of a product. An expiration dating period determined by the stability of each of its fractions shall be assigned to each product. Stability shall be determined with a stability-indicating assay that can detect changes over time in the pertinent properties of the product. Stability criteria include the specifications for potency at release, potency throughout the dating period, and the length of the dating period. When tested at any time during the dating period, the potency of the product shall not be less than the minimum specified in the filed Outline of Production. Prior to licensure, the licensee shall propose an expiration dating period for the product based on preliminary data available about the stability of each of its fractions. If the preliminary stability data are acceptable, the product may be licensed with the provision that the proposed expiration dating period must be confirmed by conducting a real-time stability study with a stabilityindicating assay as follows: (a) In the case of a newly licensed product with acceptable preliminary stability data and the real-time stability study is not conducted in animals, at least three production serials of the product shall be selected and tested during the proposed dating period. Each serial shall be tested beginning on the day of filling into final containers or the date of final formulation specified in the filed Outline of Production, and at the following intervals: (1) Every 3 months during the first year of storage, (2) Every 6 months during the second year of storage, and (3) Annually thereafter throughout the proposed dating period. (b) In the case of a newly licensed product with acceptable preliminary stability data and the real-time stability study is conducted in animals, at least three production serials shall be tested as follows: (1) One test per serial shall be conducted beginning on the day of filling into final containers or the date of final formulation specified in the filed Outline of Production. (2) One test per serial shall be conducted at thebe end of the proposed dating period. (3) One test per serial shall be conducted between the initial and final test, but at a different interval for each serial. VerDate Mar<15>2010 15:08 Sep 16, 2010 Jkt 220001 (c) In the case of a newly licensed product, and licensed products whose stability studies were completed prior to [Effective date of final rule], a real-time stability study conducted with a stability-indicating assay in accordance with paragraphs (a) or (b) of this section shall be completed in support of changes to one of the stability criteria or for major changes to the potency test. (d) In the case of a licensed product with an unconfirmed expiration dating period that is tested in animals with a test that is not a stability-indicating assay, the following shall apply: (1) Testing involving the use of a nonstability-indicating assay specified in the filed Outline of Production to confirm the expiration dating period for such product shall be completed by [Date 42 months after effective date of the final rule], or (2) Subsequent to [Date 42 months after effective date of the final rule], such testing to confirm expiration dating shall be completed with a stability-indicating assay. Products not meeting the requirement to confirm the expiration dating with a stabilityindicating assay shall be withheld from the market. (e) At the completion of the real-time stability study to confirm or change expiration dating, the data shall be submitted to Animal and Plant Health Inspection Service for approval for filing and the approved for filing date shall be specified in section VI of the filed Outline of Production at the next revision. (f) For products licensed subsequent to [Effective date of the final rule], the licensee or permittee shall submit a plan to monitor the stability of the product and the suitability of its dating period that includes regularly testing serials for potency with a stability-indicating assay during and at the end of dating. Done in Washington, DC, this 3rd day of September 2010. John Ferrell, Deputy Under Secretary for Marketing and Regulatory Programs. [FR Doc. 2010–23186 Filed 9–16–10: 10:57 am] BILLING CODE 3410–34–S PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 56919 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 167 [Docket No. USCG–2010–0785] Port Access Route Study: The Approaches to San Francisco Coast Guard, DHS. Notice of public meetings; request for comments. AGENCY: ACTION: The Coast Guard announces a public meeting to receive comments on the study entitled ‘‘Port Access Route Study: Off San Francisco’’ that was published in the Federal Register on Thursday, December 10, 2009. As stated in that document, the Coast Guard is conducting a Port Access Route Study (PARS) to evaluate the continued applicability of and the potential need for modifications to the current vessel routing in the approaches to San Francisco. SUMMARY: A Public meeting will be held on Wednesday, October 20, 2010 from 6:30 p.m. to 8:30 p.m. to provide an opportunity for oral comments. Written comments and related material may also be submitted to Coast Guard personnel specified at the meetings. ADDRESSES: The October 20, 2010 public meeting will be held at the Executive Inn and Suites at 1755 Embarcadero, Oakland, California. Visitor parking is available in the lots outside the hotel. FOR FURTHER INFORMATION CONTACT: If you have questions concerning the meeting or the study, please call or email LTJG Lucas Mancini, Coast Guard; telephone 510–437–3801, e-mail Lucas.W.Mancini@uscg.mil. If you have questions on viewing the docket call Ms. Renee V. Wright, Program Manager, Docket Operations, telephone 202–366– 9826. SUPPLEMENTARY INFORMATION: DATES: Background and Purpose We published a notice of study in the Federal Register on December 10, 2009 (74 FR 65543), entitled ‘‘Port Access Route Study: Off San Francisco’’ in which we did not state a plan to hold a public meeting. We have decided to hold a meeting in order to give the public and waterway users a chance to comment in person. In the notice of PARS, we discussed our intent to help reduce the risk of marine casualties and increase the efficiency of vessel traffic in the study region. Our goal is to assess whether the current vessel routing system is effective E:\FR\FM\17SEP1.SGM 17SEP1 56920 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules in its predictability of vessel movements, which may decrease the potential for collisions, oil spills, and other events that could threaten the marine environment. You may view the notice of PARS in our online docket, in addition to comments submitted thus far by going to http://www.regulations.gov. Once there, insert ‘‘USCG–2009–0576’’ in the ‘‘keyword’’ box and click ‘‘search.’’ If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility. We encourage you to participate in this study by submitting comments at the meeting either orally or in writing. If you bring written comments to the meeting, you may submit them to Coast Guard personnel specified at the meeting to receive written comments. These comments will be posted to our online public docket. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316). Information on Service for Individuals With Disabilities For information on facilities or services for individuals with disabilities or to request special assistance at the public meeting, contact LTJG Lucas Mancini at the telephone number or email address indicated under the FOR FURTHER INFORMATION CONTACT section of this notice. wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1 Public Meeting The Coast Guard will hold a public meeting regarding its Port Access Route Study in the Approaches to San Francisco on Wednesday October 20, 2010 from 7 p.m. to 9 p.m. at the Executive Inn and Suites located at 1755 Embarcadero, Oakland California, telephone 510–536–6633. We will provide a written summary of the VerDate Mar<15>2010 15:08 Sep 16, 2010 Jkt 220001 meeting and additional comments received at the meeting in the docket. facilities. Currently, Express Mail Open and Distribute service follows the same mailing requirements and delivery Dated: September 2, 2010. standards as Express Mail service. S.P. Metruck, The requirement to use the Express Captain, U.S. Coast Guard, Acting Mail Label 11 series with a 13-digit Commander, Eleventh Coast Guard District. barcode prevents the Postal Service [FR Doc. 2010–23176 Filed 9–16–10; 8:45 am] from differentiating between Express BILLING CODE 9110–04–P Mail and Express Mail Open and Distribute products. The delivery standards for Express POSTAL SERVICE Mail service are intended for residential/business customers and as a 39 CFR Part 111 result are delivered by 12 noon or 3 p.m. Express Mail Open and Distribute is a Express Mail Open and Distribute and product that is delivered to a processing Priority Mail Open and Distribute facility or delivery unit for further processing of the contents. AGENCY: Postal ServiceTM. To account for the Express Mail Open ACTION: Proposed rule. and Distribute product, the Postal SUMMARY: The Postal Service proposes Service is proposing to require mailers to revise Mailing Standards of the to place a single-ply address label with United States Postal Service, Domestic a service barcode on all Express Mail Mail Manual (DMM®) 705.16 to require Open and Distribute containers and to the use of a single-ply address label submit an electronic file. The service containing a service barcode with barcode is required to be a USS 128 or unique Service Type Code ‘‘723’’ or a Code 39 barcode with a ‘‘DB’’ prefix, or ‘‘DB’’ prefix along with new Tag 257, Tag concatenated GS1–128 (eVS approved 267, or Label 257S, on all Express Mail® mailers) symbology with a unique Open and Distribute containers. The Service Type Code (STC) ‘‘723’’. The Postal Service also proposes to revise text, ‘‘USPS SCAN ON ARRIVAL,’’ must the service commitment for Express appear above the barcode. This scan Mail Open and Distribute as a information is exclusive to the Open guaranteed end of day product; and to and Distribute service and will assist in add a five-pound minimum weight facilitating correct scan behavior. This proposed requirement is in requirement for Express Mail Open and accordance with instructions for Distribute and Priority Mail® Open and barcode specifications, electronic file Distribute sacks. format and testing, and the certification DATES: Submit comments on or before process in Publication 91, Confirmation October 18, 2010. Services Technical Guide. ADDRESSES: Mail or deliver written The Postal Service also proposes to comments to the Manager, Mailing replace Tag 157 with Tag 257 (DDU), Standards, U.S. Postal Service, 475 Tag 267 (SCF, NDC), and Label 257S L’Enfant Plaza, SW., Room 4446, (DDU), to assist in the verification of the Washington, DC 20260–4446. Copies of arrival at the destination facility for all all written comments will be available Express Mail Open and Distribute for inspection and photocopying containers. between 9 a.m. and 4 p.m., Monday Generally, the Postal Service through Friday, at the Postal Service processing window is 12 noon to 6 a.m. Headquarters Library, 475 L’Enfant The window to dispatch mail from Plaza, SW., 11th Floor North, plants to delivery units is from 4 a.m. Washington, DC 20260–0004. E-mail to 9 a.m. To better align the Express comments, containing the name and Mail Open and Distribute product with address of the commenter, may be sent processing and dispatch windows, to: MailingStandards@usps.gov, with a without loss of service, we are subject line of ‘‘Open and Distribute proposing to change the service Changes Comments.’’ Faxed comments commitment to end of day (11:59 p.m.). are not accepted. Express Mail and Priority Mail FOR FURTHER INFORMATION CONTACT: Jewelyn Harrington at 202–268–7648 or In addition, processing facilities Garry Rodriguez at 202–268–7281. currently receive Express Mail Open and Distribute and Priority Mail Open SUPPLEMENTARY INFORMATION: and Distribute sacks containing mail Express Mail that weighs less than five pounds, Express Mail Open and Distribute making it difficult to identify that the service is designed to provide mailers sack contains mail. The handling of low volume sacks in with expedited service to destination delivery units and other mail processing plants has been indentified as PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\17SEP1.SGM 17SEP1

Agencies

[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Proposed Rules]
[Pages 56919-56920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23176]


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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 167

[Docket No. USCG-2010-0785]


Port Access Route Study: The Approaches to San Francisco

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meetings; request for comments.

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SUMMARY: The Coast Guard announces a public meeting to receive comments 
on the study entitled ``Port Access Route Study: Off San Francisco'' 
that was published in the Federal Register on Thursday, December 10, 
2009. As stated in that document, the Coast Guard is conducting a Port 
Access Route Study (PARS) to evaluate the continued applicability of 
and the potential need for modifications to the current vessel routing 
in the approaches to San Francisco.

DATES: A Public meeting will be held on Wednesday, October 20, 2010 
from 6:30 p.m. to 8:30 p.m. to provide an opportunity for oral 
comments. Written comments and related material may also be submitted 
to Coast Guard personnel specified at the meetings.

ADDRESSES: The October 20, 2010 public meeting will be held at the 
Executive Inn and Suites at 1755 Embarcadero, Oakland, California. 
Visitor parking is available in the lots outside the hotel.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the 
meeting or the study, please call or e-mail LTJG Lucas Mancini, Coast 
Guard; telephone 510-437-3801, e-mail Lucas.W.Mancini@uscg.mil. If you 
have questions on viewing the docket call Ms. Renee V. Wright, Program 
Manager, Docket Operations, telephone 202-366-9826.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    We published a notice of study in the Federal Register on December 
10, 2009 (74 FR 65543), entitled ``Port Access Route Study: Off San 
Francisco'' in which we did not state a plan to hold a public meeting. 
We have decided to hold a meeting in order to give the public and 
waterway users a chance to comment in person.
    In the notice of PARS, we discussed our intent to help reduce the 
risk of marine casualties and increase the efficiency of vessel traffic 
in the study region. Our goal is to assess whether the current vessel 
routing system is effective

[[Page 56920]]

in its predictability of vessel movements, which may decrease the 
potential for collisions, oil spills, and other events that could 
threaten the marine environment.
    You may view the notice of PARS in our online docket, in addition 
to comments submitted thus far by going to http://www.regulations.gov. 
Once there, insert ``USCG-2009-0576'' in the ``keyword'' box and click 
``search.'' If you do not have access to the Internet, you may view the 
docket online by visiting the Docket Management Facility in Room W12-
140 on the ground floor of the Department of Transportation West 
Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 
a.m. and 5 p.m., Monday through Friday, except Federal holidays. We 
have an agreement with the Department of Transportation to use the 
Docket Management Facility.
    We encourage you to participate in this study by submitting 
comments at the meeting either orally or in writing. If you bring 
written comments to the meeting, you may submit them to Coast Guard 
personnel specified at the meeting to receive written comments. These 
comments will be posted to our online public docket. All comments 
received will be posted without change to http://www.regulations.gov 
and will include any personal information you have provided.
    Anyone can search the electronic form of comments received into any 
of our dockets by the name of the individual submitting the comment (or 
signing the comment, if submitted on behalf of an association, 
business, labor union, etc.). You may review a Privacy Act notice 
regarding our public dockets in the January 17, 2008, issue of the 
Federal Register (73 FR 3316).

Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with 
disabilities or to request special assistance at the public meeting, 
contact LTJG Lucas Mancini at the telephone number or e-mail address 
indicated under the FOR FURTHER INFORMATION CONTACT section of this 
notice.

Public Meeting

    The Coast Guard will hold a public meeting regarding its Port 
Access Route Study in the Approaches to San Francisco on Wednesday 
October 20, 2010 from 7 p.m. to 9 p.m. at the Executive Inn and Suites 
located at 1755 Embarcadero, Oakland California, telephone 510-536-
6633. We will provide a written summary of the meeting and additional 
comments received at the meeting in the docket.

    Dated: September 2, 2010.
S.P. Metruck,
Captain, U.S. Coast Guard, Acting Commander, Eleventh Coast Guard 
District.
[FR Doc. 2010-23176 Filed 9-16-10; 8:45 am]
BILLING CODE 9110-04-P