57610 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 

the Collection of Platelets, Pheresis.’’ In 

addition, in recent years, many 

improvements have been made in 

automated blood cell separator 

technology and blood cell counting 

methods. Automated blood cell 

separator devices are now capable of 

various plateletpheresis collection 

procedures including, but not limited 

to, collection of double and triple 

platelet components obtained during a 

single procedure; use of in-process 

leukocyte reduction; collection of 

concurrent plasma components; and 

collection of concurrent Red Blood Cell 

components. When finalized, the draft 

guidance will replace the October 1988 

guideline. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This 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 collections of information in 

this guidance are under FDA’s 

regulations at parts 211, 601, 606, 610, 

and 640 (21 CFR parts 211, 601, 606, 

610, and 640). Part 211, subpart J 

(Records and Reports) was approved 

under OMB control number 0910–0139; 

part 606, subpart I (Records and 

Reports) was approved under OMB 

control numbers 0910–0116 and 0910–

0458. Sections 606.100(b) and (c), 

606.110(a), 606.121, 606.122, 640.25, 

and 640.27 were approved under OMB 

control number 0910–0116; §§ 211.22, 

211.80, 211.100(b), and 211.160 were 

approved under OMB control number 

0910–0139; § 610.2 was approved under 

OMB control number 0910–0206; and 

§§ 601.12 and 610.60 were approved 

under OMB Control No. 0910–0338. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. 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 the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: September 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19727 Filed 9–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0390] 

International Conference on 

Harmonisation; Draft Guidance on 

E2B(R) Clinical Safety Data 

Management: Data Elements for 

Transmission of Individual Case Safety 

Reports; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘E2B(R) Clinical Safety Data 

Management: Data Elements for 

Transmission of Individual Case Safety 

Reports.’’ The draft guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance, which revises 

previous guidance on the same topic, 

provides standardized data elements for 

the transmission of individual case 

safety reports for preapproval and 

postapproval reporting periods. The 

revisions in this draft guidance include 

additional information and 

clarifications for the electronic 

transmission of individual case safety 

reports. The draft guidance is intended 

to be used with other ICH 

recommendations for electronic 

transmissions. 

DATES: Submit written or electronic 

comments on the draft guidance by 

October 28, 2005. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: 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. 

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; or the Office of 

Communication, Training and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The draft 

guidance may also be obtained by mail 

by calling the Center for Biologics 

Evaluation and Research (CBER) Voice 

Information System at 1–800–835–4709 

or 301–827–1800. Send two selfaddressed adhesive labels to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Roger 

Goetsch, Center for Drug Evaluation 

and Research (HFD–410), Food and 

Drug Administration, 12300 

Twinbrook Pkwy., Rockville, MD 

20851, 301–770–9299, or Lise 

Stevens-Hawkins, Center for 

Biologics Evaluation and Research 

(HFM–220), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–6085. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 57611 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

The ICH guidance entitled ‘‘E2B Data 

Elements for Transmission of Individual 

Case Safety Reports’’ was signed off by 

ICH in July 1997 and issued by FDA in 

January 1998 (63 FR 2396, January 15, 

1998). ICH subsequently issued a 

revised guidance entitled ‘‘E2B(M) 

Clinical Safety Data Management: Data 

Elements for Transmission of Individual 

Case Safety Reports’’ (E2B(M)), to 

provide additional information and 

clarification. ICH signed off on E2B(M) 

in November 2001, and FDA issued the 

revised guidance in April 2002. 

In May 2005, the ICH Steering 

Committee agreed that the E2B(M) draft 

guidance should be made available for 

public comment. The draft guidance is 

the product of the E2B(R) Expert 

Working Group of the ICH. Comments 

about the draft guidance will be 

considered by FDA and the E2B(R) 

Expert Working Group. 

FDA is announcing the availability of 

the draft guidance entitled ‘‘E2B(R) 

Clinical Safety Data Management: Data 

Elements for Transmission of Individual 

Case Safety Reports,’’ which revises the 

previous E2B guidances to include 

additional information and clarification 

for the electronic transmission of 

individual case safety reports. The draft 

guidance incorporates adjustments 

based on experience gained after 

implementation of the guidance in the 

three ICH regions and expands the use 

of the standard data elements to support 

vaccine reporting. For electronic 

transmissions, the draft guidance is 

intended to be used with the ICH M2 

individual case safety report (ICSR) 

message specification. The draft 

guidance recommends that electronic 

transmission of individual case safety 

reports be implemented using the 

Medical Dictionary for Regulatory 

Activities (MedDRA) and ICH M5 data 

elements and standards where 

applicable. 

FDA has identified in public Docket 

No. 1992S–0251 (formerly Docket No. 

92S–0251) postmarketing individual 

case safety reports as submission types 

that the agency can accept in electronic 

format. FDA believes the ICH 

recommendations for the electronic 

transmission of these reports will result 

in more effective and efficient safety 

reporting to regulatory authorities 

worldwide. 

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 this topic. 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 on the draft guidance. 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. The draft guidance and 

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 http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/publications.htm. 

Dated: September 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19655 Filed 9–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

Waiver of Compliance With Navigation 

and Inspection Laws; Gulf Coast 

States 

AGENCY: Office of the Secretary, DHS. 

ACTION: Notice. 

The combined effect of Hurricanes 

Rita and Katrina is one of the largest 

natural disasters to ever strike the 

United States. The hurricanes have 

significantly disrupted production of oil 

and gas in the Gulf of Mexico, have 

caused many Gulf Coast oil refineries to 

go out of service because of flooding, 

lack of electric power or other reasons, 

and have significantly disrupted the 

pipeline transportation of oil and 

refined products from the Gulf Coast 

States. These production losses, outages, 

and disruptions have caused increases 

in the price of oil, gasoline and other 

refined products. The Department of 

Homeland Security has received reports 

of threatened or actual shortages of 

gasoline, jet fuel, and/or other refined 

products as a result of the hurricanes. 

Companies that produce and/or ship 

petroleum and/or refined petroleum 

products have submitted to the 

Department requests for waivers of the 

Merchant Marine Act of 1920 (the 

‘‘Jones Act’’). See, 46 U.S.C. App. 

section 1; 46 U.S.C. App. section 883. 

This and related laws are generally 

referred to as the ‘‘coastwise laws.’’

These laws provide, among other things, 

that only vessels built and owned by 

citizens of the United States and flagged 

in the United States can carry 

merchandise between U.S. ports. 

The Secretary of Homeland Security 

is vested with the authority and 

discretion to waive the coastwise laws 

‘‘to such extent and in such manner and 

upon such terms as he may prescribe, 

either upon his own initiative or upon 

the written recommendation of the head 

of any other Government agency, 

whenever he deems that such action is 

necessary in the interest of national 

defense.’’ In consultation with and upon 

the recommendation of the Secretary of 

Energy, I have determined that such a 

waiver, in accordance with the terms set 

forth below, is in the interest of the 

national defense.