Federal Register / Vol. 70, No. 166 / Monday, August 29, 2005 / Notices 51077 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0312] 

Draft Guidance for Industry on 

Abbreviated New Drug Applications: 

Impurities in Drug Products; 

Chemistry, Manufacturing, and 

Controls Information; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘ANDAs: Impurities in 

Drug Products; Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on what 

chemistry, manufacturing, and controls 

information sponsors should include 

regarding reporting, identification, 

qualification, and setting acceptance 

criteria for impurities that are classified 

as degradation products in drug 

products when submitting an 

abbreviated new drug application 

(ANDA) or supplement to support 

changes in drug substance synthesis or 

process, formulation of the drug 

product, the manufacturing process, or 

components of the container/closure 

system. 

DATES: Submit written or electronic 

comments on the draft guidance by 

November 28, 2005. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Devinder Gill, Center for Drug 

Evaluation and Research (HFD–630), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 5, 

1999 (64 FR 516), FDA published the 

draft guidance for industry on ‘‘ANDAs: 

Impurities in Drug Products.’’ The draft 

guidance provided recommendations for 

including information in ANDAs and 

ANDA supplements about the reporting, 

identification, qualification of, and 

setting acceptance criteria for 

degradation products in drug products 

that are manufactured from drug 

substances produced by chemical 

synthesis. 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘ANDAs: Impurities in Drug 

Products,’’ which revises the January 5, 

1999, draft guidance. The draft guidance 

is being revised to update information 

on listing of degradation products, 

setting acceptance criteria, and 

qualifying degradation products in 

conformance with our current thinking 

and the revision of the International 

Conference on Harmonisation of 

Technical Requirements for Registration 

of Pharmaceuticals for Human Use (ICH) 

guidance for industry on ‘‘Q3B(R) 

Impurities in New Drug Products,’’

published in November 2003. The draft 

guidance is also being revised to remove 

sections of the guidance containing 

recommendations that are no longer 

needed because they are addressed in 

the more recent Q3B(R). 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collection of 

information in this draft guidance was 

approved under OMB Control No. 0910–

0001. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on these topics. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: August 16, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17150 Filed 8–26–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[CGD17–05–0010] 

Annual Certification of Cook Inlet 

Regional Citizen’s Advisory Council 

(CIRCAC) 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of recertification. 

SUMMARY: Under the Oil Terminal and 

Tanker Environmental Oversight Act of 

1990, the Coast Guard may certify on an 

annual basis an alternative voluntary 

advisory group in lieu of a regional 

citizens’ advisory council for Cook Inlet, 

Alaska. This certification allows the 

advisory group to monitor the activities 

of terminal facilities and crude oil 

tankers under the Cook Inlet Program 

established by the statute. The purpose 

of this notice is to inform the public that 

the Coast Guard has recertified the 

alternative voluntary advisory group for 

Cook Inlet, Alaska. 

DATES: This recertification is effective 

for the period from September 1, 2005 

through August 31, 2006. 

FOR FURTHER INFORMATION CONTACT: For 

general information regarding the 

CIRCAC or viewing material submitted 

to the docket, contact Rick Janelle, 

Seventeenth Coast Guard District, 

Marine Safety Division, (907) 463–2808. 

SUPPLEMENTARY INFORMATION: In section 

5002 of the Oil Pollution Act of 1990, 

cited as the Oil Terminal and Tanker 

Environmental Oversight and 

Monitoring Act of 1990 (the Act), 

Congress sought to foster the long-term 

partnership among industry, 

government, and local communities in 

overseeing compliance with the 

environmental concerns in the 

operation of terminal facilities and 

51078 Federal Register / Vol. 70, No. 166 / Monday, August 29, 2005 / Notices 

crude-oil tankers. Subsection 5002(o) 

permits an alternative voluntary 

advisory group to represent to 

communities and interests in the 

vicinity of the terminal facilities in Cook 

Inlet (CI), in lieu of a council of the type 

specified in subsection 5002(d), if 

certain conditions are met. 

The Act requires that the group enter 

into a contract to ensure annual 

funding, and that it receive annual 

certification by the President to the 

effect that it fosters the general goals 

and purposes of the Act, and is broadly 

representative of the communities and 

interests in the vicinity of the terminal 

facilities and Cook Inlet. Accordingly, in 

1991, the President granted certification 

to the Cook Inlet Regional Citizen’s 

Advisory Council (CIRCAC). The 

authority to certify alternative advisory 

groups was subsequently delegated to 

the Commandant of the Coast Guard and 

redelegated to the Commander, 

Seventeenth Coast Guard District. 

On June 28, 2005, the Coast Guard 

published a notice of availability of an 

application for recertification submitted 

by the Cook Inlet Regional Citizens’

Advisory Council in the Federal 

Register (70 FR 37103) and we 

requested comments. Eight comments 

were received. 

Discussion of Comments 

Of the comments received, all were 

supportive of recertification and noted 

the positive efforts, good 

communication, and broad 

representation of Cook Inlet 

communities by CIRCAC as it carries 

out its responsibilities as intended by 

the Act. 

The Coast Guard received one letter of 

public comment from the Cook Inlet 

Keeper, a citizen-based, non-profit 

group dedicated to protecting Alaska’s 

Cook Inlet watershed. This comment 

supported the recertification of the 

CIRCAC and also encouraged the Coast 

Guard to investigate ways to ensure the 

CIRCAC has a more reliable, long-term 

funding stream. Although the Coast 

Guard understands the Cook Inlet 

Keeper’s concern, the Coast Guard is 

limited to determining whether the 

CIRCAC has entered into a contract for 

funding in accordance with the 

requirements of 33 U.S.C. 2732(o), and 

reviewing the expenditure of those 

funds. 

Upon review of the comments 

received regarding the CIRCAC’s 

performance during the past year and 

the information provided by the RCAC 

in their annual report and recertification 

package, the Coast Guard finds the 

CIRCAC meets the criteria established 

under the Oil Pollution Act, and that 

recertification in accordance with the 

Act is appropriate. 

Recertification 

By letter dated 12 August, 2005 the 

Commander, Seventeenth Coast Guard, 

certified that the CIRCAC qualifies as an 

alternative voluntary advisory group 

under 33 U.S.C. 2732(o). This 

recertification lasts through August 31, 

2006. 

Dated: August 15, 2005. 

James C. Olson, 

Rear Admiral, U.S. Coast Guard, Commander, 

Seventeenth Coast Guard District. 

[FR Doc. 05–17093 Filed 8–26–05; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2005–22235] 

Towing Safety Advisory Committee 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting. 

SUMMARY: The Licensing 

Implementation Working Group of the 

Towing Safety Advisory Committee 

(TSAC) will meet to discuss matters 

relating to specific issues of towing 

safety. The meeting will be open to the 

public. 

DATES: The Licensing Implementation 

Working Group will meet via 

teleconference on Friday, September 2, 

2005 from 10 a.m. to approximately 12 

noon EDT. Written material and 

requests to make oral presentations 

should reach the TSAC working group 

Chairperson on or before August 30, 

2005. 

ADDRESSES: The Working Group will 

meet via conference call only. Contact 

Ms. Jennifer Carpenter, working group 

Chairperson, or her assistant, Ms. Amy 

Hewett at 703–841–9300 for the 

conference call telephone number and 

access code. Send written material and 

requests to make oral presentations to 

Ms. Jennifer Carpenter; American 

Waterways Operators; 801 North Quincy 

Street, Suite 200; Arlington, VA 22209. 

This notice and related documents are 

available on the Internet at http:// 

dms.dot.gov under the docket number 

USCG–2005–22235. 

FOR FURTHER INFORMATION CONTACT: For 

general TSAC information you may also 

contact Mr. Gerald Miante, Assistant 

Executive Director of TSAC, telephone 

202–267–0214, fax 202–267–4570, or email gmiante@comdt.uscg.mil. If you 

plan to participate in this meeting, 

please notify both Mr. Miante and either 

Ms. Carpenter or Ms. Hewett by August 

30, 2005. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act, 5 

U.S.C. App. 2 (Pub. L. 92–463, 86 

Stat.770, as amended). 

Agenda of Working Group Meeting 

The agenda for the Licensing Working 

Group tentatively includes the following 

items: 

(1) Time frame flexibility—

• Credit apprentice mate/steersman 

time at higher rate if individual is 

carried as an extra person; 

• Model course; 

(2) Combine inland and Western 

Rivers routes; 

(3) Ability to upgrade from tonnagelimited Master of Towing Vessels to 

Master of Towing Vessels without 

tonnage Limitation; 

(4) Require towing endorsement for 

Master of Steam or Motor Vessels of Not 

More Than 500 Gross Tons. (Current 

regs allow Master 500 to operate towing 

vessels if he/she has either a towing 

endorsement or a completed Towing 

Officer’s Assessment Record (TOAR.); 

(5) Clarify how Master of Towing 

Vessels can obtain a Standards of 

Training, Certification and 

Watchkeeping (STCW) certificate if 

needed; 

(6) Reconcile apparent discrepancies 

between licensing regulations and 

Navigation and Vessel Inspection 

Circular (NVIC) 4–01 Licensing and 

Manning for Officers of Towing Vessels 

re. TOAR format; 

(7) Clarify TOAR requirements for 

harbor tug operators. Can certain items 

be marked ‘‘Not Applicable’’ (N/A)?; 

(8) Reconsider elements that may 

prolong time needed to complete a 

TOAR (e.g., operate in high water, high 

wind.); 

(9) Work with the Coast Guard to 

develop a communications plan aimed 

at mariners; and 

(10) Proposed changes to NVIC 4–01. 

A letter proposing changes is attached; 

the NVIC can be found on-line at: http:// 

www.uscg.mil/hq/g-m/nvic/ 

index00.htm#2001. 

Procedural 

The meeting is open to the public. 

Please note that the meeting may close 

early if all business is finished. At the 

Chair’s discretion, members of the 

public may make oral presentations 

during the meeting. If you would like to 

make an oral presentation at the 

meeting, please notify the working 

group Chairperson (as provided above 

in ADDRESSES no later than August 30,