5552 Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 

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.

In the Federal Register of December 

31, 2002 (67 FR 79939), FDA published 

a notice announcing the availability of 

a draft tripartite guidance entitled 

‘‘Addendum to E2C Clinical Safety Data 

Management: Periodic Safety Update 

Reports for Marketed Drugs.’’ The notice 

gave interested persons an opportunity 

to submit comments by January 24, 

2003.

After consideration of the comments 

received and revisions to the draft 

guidance, a final draft of the guidance 

was submitted to the ICH steering 

committee and endorsed by the three 

participating regulatory agencies in 

February 2003.

This guidance provides additional 

information on the objectives, general 

principles, and model for PSURs 

specified in the ICH E2C guidance, 

including clarification of the following 

topics:

• When separate PSURs will be 

considered appropriate,

• Synchronization of National 

Birthdates with the International 

Birthdates,

• Reporting frequency and time for 

submission changes, and

• Use of the reference safety 

information.

In addition, this guidance includes 

information on the following topics not 

previously addressed in the ICH E2C 

guidance.

• Summary bridging reports and 

addendum reports,

• Executive summaries, and

• Information on risk management 

programs and risk-benefit analyses.

The document should be used in 

conjunction with the ICH E2C guidance.

This 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 requirements of the 

applicable statutes and regulations.

II. Comments

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written 

comments on the guidance. Two copies 

of any comments are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. The 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: January 23, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–2314 Filed 2–4–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0041]

Draft Guidance for Industry on 

Providing Regulatory Submissions in 

Electronic Format—Content of 

Labeling; 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 ‘‘Providing Regulatory 

Submissions in Electronic Format—

Content of Labeling.’’ This draft 

guidance is one in a series of guidance 

documents on providing regulatory 

submissions to the FDA in electronic 

format. In the Federal Register of 

December 11, 2003 (68 FR 69009), FDA 

published a final regulation (the 

electronic labeling rule) requiring that 

the content of labeling for marketing 

applications be submitted in electronic 

format in a form that FDA can process, 

review, and archive. The draft guidance 

provides information on submitting the 

content of labeling in electronic format 

for review with new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), and biological 

license applications (BLAs).

DATES: Submit written comments on the 

draft guidance by April 5, 2004. 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, or to 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. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. 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:

Randy Levin, Center for Drug Evaluation 

and Research (HFD–140), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–

594–5411, e-mail: 

levinr@cder.fda.gov, or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852, 301–827–0373.

SUPPLEMENTARY INFORMATION:

I. Background

In December 2003, FDA published the 

electronic labeling regulation, which 

requires the submission of the content 

of labeling in electronic format for 

marketing applications. The 

requirements of the electronic labeling 

rule can be found in 21 CFR 314.50(l) 

for NDAs, 21 CFR 314.94(d) for ANDAs, 

21 CFR 601.14(b) for BLAs, and 21 CFR 

314.81(b) for annual reports on 

marketing applications. The regulations 

specify that the content of labeling must 

be submitted electronically in a form 

that FDA can process, review, and 

archive. The regulations also state that 

FDA will periodically issue guidance on 

how to provide the electronic 

submission.

II. The Draft Guidance

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Content of 

Labeling.’’ The draft guidance provides 

information on how to submit the 

content of labeling in electronic format.

In the preambles of the proposed and 

final rules on electronic labeling, FDA 

identified portable document format 

(PDF) as the only type of electronic file 

format that the agency has the ability to 

Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 5553

accept for processing, reviewing, and 

archiving. Recent recommendations 

from the Institute of Medicine and the 

National Committee on Vital and Health 

Statistics and mandates in the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (Public Law 

108–173) have created a new role for 

electronic labeling information. 

Electronically formatted content of 

labeling will be used to support health 

information management initiatives 

such as electronic prescribing and the 

electronic health record (EHR).

Because FDA’s current procedures 

using PDF are not adequate to support 

these initiatives, the agency is proposing 

to change the way it processes, reviews, 

and archives the content of labeling. We 

are proposing to adopt a new technology 

for exchanging information between 

computer systems developed by Health 

Level Seven (HL7), a standards 

development organization accredited by 

the American National Standards 

Institute. The new technology, Clinical 

Document Architecture (CDA), allows 

information to be exchanged in 

extensible markup language (XML) and 

is the standard being investigated for the 

EHR. FDA, working with other 

interested parties in HL7, has adapted 

CDA for labeling in a proposed HL7 

standard called Structured Product 

Labeling (SPL).

FDA is developing an automated 

system using SPL for processing and 

managing labeling and labeling changes. 

When the draft guidance is finalized, 

absent significant objections, FDA is 

likely to identify SPL in public docket 

number 92S–0251 as a format that we 

can use to process, review, and archive 

the content of labeling. During our 

transition to the automated system, the 

agency would be able to accept the 

content of labeling in either PDF or SPL 

file format. After the automated system 

is implemented, PDF would no longer 

be a format that we can use to process, 

review, and archive the content of 

labeling. At this time, it is our goal to 

complete the transition to SPL format 

for content of labeling submissions by 

the end of 2004.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices (GGPs) regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on providing in 

electronic format the content of labeling 

required in 21 CFR parts 314 and 601. 

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.

III. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one 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 are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

The information requested for human 

drug and biological products in this 

guidance is already covered by the 

collection of information in 

‘‘Requirements for Submission of 

Labeling for Human Prescription Drugs 

and Biologics in Electronic Format’’

(Office of Management and Budget 

control number 0910–0530, expiring 

November 30, 2006).

V. Electronic Access

Persons with access to the Internet 

may obtain the document at http://

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

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

guidelines.htm, or at http://

www.fda.gov/ohrms/dockets/

default.htm.

Dated: January 25, 2004.

William K. Hubbard,

Associate Commissioner for Policy and 

Planning.

[FR Doc. 04–2536 Filed 2–3–04; 9:39 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute Proposed Collection; 

Comment Request Exam 2—The 

Jackson Heart Study, Annual FollowUp Component 

Summary: Under the provisions of 

section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on September 9, 2003, pages 

53177–53178, and allowed 60-days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection: Title: The 

Jackson Heart Study: Annual Follow-up 

with Third Party Respondents. Type of 

Information Collection Request:

Revision of a currently approved 

collection (OMB 0925–0491). Need and 

Use of Information Collection: This 

project involves follow-up by telephone 

of participants in the JHS study, review 

of their medical records, and interviews 

with doctors and family to identify 

disease occurrence. Interviewers will 

contact doctors and hospitals to 

ascertain participants’ cardiovascular 

events. Information gathered will be 

used to further describe the risk factors, 

occurrence rates, and consequences of 

cardiovascular disease in African 

American men and women. The 

continuation of the study will allow 

continued assessment of subclinical 

coronary disease, left ventricular 

dysfunction, progression of carotid 

atherosclerosis and left ventricular 

hypertrophy, and responses to stress, 

racism, and discrimination as well as 

new components such as renal disease, 

body fat distribution and body 

composition, and metabolic 

consequences of obesity. Frequency of 

Response: One-time. Affected Public:

Individuals or families; businesses or 

other for profit; not-for-profit 

institutions. Affected Public: Third 

party respondents (next-of-kin 

decedents and physicians). Type of 

Respondents: Middle aged and elderly 

adults; doctors and staff of hospitals and 

nursing homes. Estimated Number of 

Respondents: 600; Estimated Number of 

Responses per Respondent: 1; Average 

Burden Hours Per Response: 0.50; and 

Estimated Total Annual Burden Hours 

Requested: 300. The annualized cost to 

respondents is estimated at: $6,500. 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report.