Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 5551

Officer for ACF, E-mail: 

katherine_t._astrich@omb.eop.gov.

Dated: January 29, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–2325 Filed 2–4–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998F–0716]

Dainippon Ink and Chemicals, Inc.; 

Withdrawal of Food Additive Petition

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal, without prejudice to a 

future filing, of a food additive petition 

(FAP 8B4619) proposing that the food 

additive regulations be amended to 

provide for the expanded safe use of a 

polyester-polyurethane resin-acid 

dianhydride adhesive in retortable 

pouches for use in contact with fatty 

food.

FOR FURTHER INFORMATION CONTACT:

Mark Hepp, Center for Food Safety and 

Applied Nutrition (HFS–275), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3858, 

202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

August 31, 1998 (63 FR 46226), FDA 

announced that a food additive petition 

(FAP 8B4619) had been filed by 

Dainippon Ink and Chemicals, Inc., c/o 

Center for Regulatory Services, 2347 

Paddock Lane, Reston, VA 20191. The 

petition proposed to amend the food 

additive regulations in § 177.1390 

Laminate structures for use at 

temperatures of 250 °F and above (21 

CFR 177.1390) to provide for the 

expanded safe use of a polyesterpolyurethane resin-acid dianhydride 

adhesive in retortable pouches for use in 

contact with fatty food. Dainippon Ink 

and Chemicals, Inc., has now 

withdrawn the petition without 

prejudice to a future filing (21 CFR 

171.7).

Dated: January 9, 2004.

Laura M. Tarantino,

Acting Director, Office of Food Additive 

Safety, Center for Food Safety and Applied 

Nutrition.

[FR Doc. 04–2313 Filed 2–4–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 1996D–0041]

International Conference on 

Harmonisation; Guidance on 

Addendum to E2C Clinical Safety Data 

Management: Periodic Safety Update 

Reports for Marketed Drugs; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Addendum to E2C Clinical Safety Data 

Management: Periodic Safety Update 

Reports for Marketed Drugs’’ (the ICH 

E2C guidance). The guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

In the Federal Register of May 19, 1997 

(62 FR 27470), FDA published the ICH 

E2C guidance, which recommends a 

unified standard for the format, content, 

and reporting frequency for 

postmarketing periodic safety update 

reports (PSURs) for drug and biological 

products. This guidance, an addendum 

to the ICH E2C guidance, provides 

additional information on the content 

and format of PSURs, including 

clarification of the objectives, general 

principles, and model for PSURs. This 

guidance is intended to help harmonize 

collection and submission of 

postmarketing clinical safety data.

DATES: You may submit written or 

electronic comments at any time.

ADDRESSES: Submit written comments 

on the 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 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, 301–827–

3844, FAX: 888–CBERFAX. Send two 

self-addressed adhesive labels to assist 

the office in processing your requests. 

Requests and comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Min Chen, 

Center for Drug Evaluation and 

Research (HFD–430), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–

827–3159, or Miles Braun, Center 

for Biologics Evaluation and 

Research (HFM–220), Food and 

Drug Administration, 1401 

Rockville Pike, Rockville, MD 

20852, 301–827–6090.

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 

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