Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 56919 

■ 5. Section 114.13 is revised to read as 

follows: 

§ 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. 

(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 

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. 

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 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: 

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 


wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1
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. 

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 

POSTAL SERVICE 

39 CFR Part 111 

Express Mail Open and Distribute and 

Priority Mail Open and Distribute 

AGENCY: Postal ServiceTM. 

ACTION: Proposed rule. 

SUMMARY: The Postal Service proposes 

to revise Mailing Standards of the 

United States Postal Service, Domestic 

Mail Manual (DMM®) 705.16 to require 

the use of a single-ply address label 

containing a service barcode with 

unique Service Type Code ‘‘723’’ or a 

‘‘DB’’ prefix along with new Tag 257, Tag 

267, or Label 257S, on all Express Mail®

Open and Distribute containers. The 

Postal Service also proposes to revise 

the service commitment for Express 

Mail Open and Distribute as a 

guaranteed end of day product; and to 

add a five-pound minimum weight 

requirement for Express Mail Open and 

Distribute and Priority Mail® Open and 

Distribute sacks. 

DATES: Submit comments on or before 

October 18, 2010. 

ADDRESSES: Mail or deliver written 

comments to the Manager, Mailing 

Standards, U.S. Postal Service, 475 

L’Enfant Plaza, SW., Room 4446, 

Washington, DC 20260–4446. Copies of 

all written comments will be available 

for inspection and photocopying 

between 9 a.m. and 4 p.m., Monday 

through Friday, at the Postal Service 

Headquarters Library, 475 L’Enfant 

Plaza, SW., 11th Floor North, 

Washington, DC 20260–0004. E-mail 

comments, containing the name and 

address of the commenter, may be sent 

to: MailingStandards@usps.gov, with a 

subject line of ‘‘Open and Distribute 

Changes Comments.’’ Faxed comments 

are not accepted. 

FOR FURTHER INFORMATION CONTACT: 

Jewelyn Harrington at 202–268–7648 or 

Garry Rodriguez at 202–268–7281. 

SUPPLEMENTARY INFORMATION: 

Express Mail 

Express Mail Open and Distribute 

service is designed to provide mailers 

with expedited service to destination 

delivery units and other mail processing 

facilities. Currently, Express Mail Open 

and Distribute service follows the same 

mailing requirements and delivery 

standards as Express Mail service. 

The requirement to use the Express 

Mail Label 11 series with a 13-digit 

barcode prevents the Postal Service 

from differentiating between Express 

Mail and Express Mail Open and 

Distribute products. 

The delivery standards for Express 

Mail service are intended for 

residential/business customers and as a 

result are delivered by 12 noon or 3 p.m. 

Express Mail Open and Distribute is a 

product that is delivered to a processing 

facility or delivery unit for further 

processing of the contents. 

To account for the Express Mail Open 

and Distribute product, the Postal 

Service is proposing to require mailers 

to place a single-ply address label with 

a service barcode on all Express Mail 

Open and Distribute containers and to 

submit an electronic file. The service 

barcode is required to be a USS 128 or 

Code 39 barcode with a ‘‘DB’’ prefix, or 

concatenated GS1–128 (eVS approved 

mailers) symbology with a unique 

Service Type Code (STC) ‘‘723’’. The 

text, ‘‘USPS SCAN ON ARRIVAL,’’ must 

appear above the barcode. This scan 

information is exclusive to the Open 

and Distribute service and will assist in 

facilitating correct scan behavior. 

This proposed requirement is in 

accordance with instructions for 

barcode specifications, electronic file 

format and testing, and the certification 

process in Publication 91, Confirmation 

Services Technical Guide. 

The Postal Service also proposes to 

replace Tag 157 with Tag 257 (DDU), 

Tag 267 (SCF, NDC), and Label 257S 

(DDU), to assist in the verification of the 

arrival at the destination facility for all 

Express Mail Open and Distribute 

containers. 

Generally, the Postal Service 

processing window is 12 noon to 6 a.m. 

The window to dispatch mail from 

plants to delivery units is from 4 a.m. 

to 9 a.m. To better align the Express 

Mail Open and Distribute product with 

processing and dispatch windows, 

without loss of service, we are 

proposing to change the service 

commitment to end of day (11:59 p.m.). 

Express Mail and Priority Mail 

In addition, processing facilities 

currently receive Express Mail Open 

and Distribute and Priority Mail Open 

and Distribute sacks containing mail 

that weighs less than five pounds, 

making it difficult to identify that the 

sack contains mail. 

The handling of low volume sacks in 

plants has been indentified as 


wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1