Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59259

summarizes clean area air classifications 

and recommended microbiological 

action levels, has been modified to 

acknowledge that alternate action levels 

can be justified depending on the 

method of analysis used. Further 

clarifications have been made regarding 

process simulations. In addition, the 

guidance recommends ‘‘building quality 

into products’’ through science-based 

facility, equipment, and systems design 

for sterile drug manufacture. We 

underscore our encouragement of 

alternate approaches and innovations to 

achieve increased sterility assurance.

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking. 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 the approach satisfies the 

requirements of the applicable statute 

and regulations.

III. 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 (PRA) (44 U.S.C. 

3501–3520). The collection of 

information in this guidance was 

approved under OMB control number 

0910–0139, until August 31, 2005.

IV. Electronic Access

Persons with access to the Internet 

may obtain the guidance at either http:/

/www.fda.gov/cder/guidance/index.htm

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

default.htm.

Dated: September 28, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22207 Filed 9–29–04; 2:14 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0414]

Guidance for Industry on Food and 

Drug Administration Review of Vaccine 

Labeling Requirements for Warnings, 

Use Instructions, and Precautionary 

Information; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: FDA Review of 

Vaccine Labeling Requirements for 

Warnings, Use Instructions, and 

Precautionary Information,’’ dated 

September 2004. The guidance 

document provides to vaccine 

manufacturers, medical practitioners, 

and consumers an overview of the 

vaccine labeling review process, a 

description of FDA’s review of 

childhood vaccine labeling, and a 

discussion of the type of data FDA 

examines when determining the 

adequacy of vaccine labeling.

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling the CBER Voice 

Information System at 1–800–835–4709 

or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document.

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.

FOR FURTHER INFORMATION CONTACT:

Astrid Szeto, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: FDA Review of Vaccine 

Labeling Requirements for Warnings, 

Use Instructions, and Precautionary 

Information,’’ dated September 2004. 

The guidance document provides to 

vaccine manufacturers, medical 

practitioners, and consumers an 

overview of the vaccine labeling review 

process, a description of FDA’s review 

of childhood vaccine labeling under 

section 314 of the National Childhood 

Vaccine Injury Act (NCVIA), and a 

discussion of the type of data FDA 

examines when determining the 

adequacy of vaccine labeling. The 

processes described represent current 

FDA practices and do not represent any 

new interpretation of existing labeling 

statutes, regulations, or guidances.

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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 requirement of the 

applicable statutes and regulations.

II. Comments

In accordance with 21 CFR 

10.115(g)(4)(i), FDA is immediately 

implementing this guidance. Interested 

persons may, at any time, submit 

written or electronic comments to the 

Division of Dockets Management (see 

ADDRESSES) regarding this 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 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.

III. Electronic Access

Persons with access to the Internet 

may obtain the guidance at either http:/

/www.fda.gov/cber/guidelines.htm or 

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

default.htm.

Dated: September 20, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22213 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Children’s Hospitals Graduate Medical 

Education Payment Program (CHGME 

PP)

AGENCY: Health Resources and Services 

Administration, HHS.

ACTION: Notice of Children’s Hospitals 

Graduate Medical Education Payment 

Program (CHGME PP) conference call. 

SUMMARY: This document announces a 

scheduled CHGME PP conference call 

for Federal fiscal year (FY) 2005. The