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When the draft guidance is finalized, 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This draft guidance is being issued 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 The draft guidance, when 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.

5554 Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 

ESTIMATE OF ANNUAL HOUR BURDEN

Type of response Number of respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

Morbidity & Mortality AFU 3rd party next-of-kin .............................................. 300 1 0.5 150

Morbidity & Mortality AFU 3rd party Physicians .............................................. 300 1 0.5 150

Total .......................................................................................................... 600 ........................ ........................ 300

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Ms. 

Cheryl Nelson, NIH, NHLBI, 6701 

Rockledge Drive, MSC 7934, Bethesda, 

MD 20892–7934, or call non-toll-free 

number (301) 435–0707 or E-mail your 

request, including your address to: 

NelsonCH@nhlbi.nih.gov.

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication.

Dated: January 30, 2004. 

Peter Savage, 

Director, DECA, NH.

[FR Doc. 04–2388 Filed 2–4–04; 8:45 am] 

BILLING CODE 4140–10–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Initial Review Group, Subcommittee 

H—Clinical Groups. 

Date: March 22, 2004. 

Time: 7:30 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard Crystal City, 2899 

Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Deborah R. Jaffe, PhD, 

Scientific Review Administrator, Resources 

and Training Review Branch, National 

Cancer Institute, Division of Extramural 

Activities, 6116 Executive Blvd., Rm 8135, 

Bethesda, MD 20892, (301) 496–7721, 

jaffed@mail.nih.gov.

Any interested person may file 

written comments with the committee 

by forwarding the statement to the 

Contact Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)

Dated: January 28, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–2376 Filed 2–4–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; Loan Repayment. 

Date: March 4–5, 2004. 

Time: 7 p.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Carol Pontzer, PhD, 

Scientific Review Administrator, National 

Center for Complementary, and Alternative 

Medicine, 6707 Democracy Blvd., Bethesda, 

MD 20892.

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; Training and 

Education. 

Date: March 4–5, 2004. 

Time: 7 p.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Carol Pontzer, PhD, 

Scientific Review Administrator, National 

Center for Complementary, and Alternative 

Medicine, 6707 Democracy Blvd., Bethesda, 

MD 20892.