Federal Register / Vol. 72, No. 52 / Monday, March 19, 2007 / Notices 12807 

1See http://www.hl7.org. (FDA has verified the 

Web site address, but FDA is not responsible for 

any subsequent changes to the Web site after this 

document publishes in the Federal Register.) 

submissions may be made to the contact 

person on or before March 28, 2007. 

Oral presentations from the public will 

be scheduled between approximately 4 

p.m. to 5 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before by March 20, 2007. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

pubic hearing session. The contact 

person will notify interested person 

regarding their request to speak by 

March 21, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please notify Carlos Pena at 

least 7 days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 8, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–4877 Filed 3–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0080] 

Draft Guidance for Industry on 

Indexing Structured Product 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availability of a draft guidance for 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 ‘‘Indexing Structured 

Product Labeling.’’ This guidance 

explains that the Center for Drug 

Evaluation and Research (CDER) will 

index structured product labeling (SPL) 

in the product labeling for human drugs. 

This guidance also makes 

recommendations to industry on how to 

request a change to the indexing 

information in the SPL. 

DATES: Submit written or electronic 

comments on the draft guidance by June 

18, 2007. 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. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

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: 

Laurie Burke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6462, 

Silver Spring, MD 20993–0002, 

laurie.burke@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Food and Drug Administration 

(FDA) is announcing the availability of 

a draft guidance for industry entitled 

‘‘Indexing Structured Product 

Labeling.’’ This guidance explains that 

FDA’s CDER will index SPL in the 

product labeling for human drugs. This 

guidance also makes recommendations 

to industry on how to request a change 

to the indexing information in the SPL. 

A Health Level Seven (HL7)1

standard, SPL is used for electronically 

exchanging the content of labeling and 

other regulated product information 

using the extensible markup language. 

The SPL standard enables the inclusion 

of indexing elements with product 

labeling. These machine-readable 

identifiers enable users, such as clinical 

decision support tools and electronic 

prescribing systems, to rapidly search 

and sort product information found in 

product labels. Indexing the SPL will 

greatly facilitate the efficient 

communication of important drug 

information to the public, helping create 

a more robust nationwide system for 

promoting the safe and effective use of 

drugs. 

After completing a 6-month pilot 

project evaluating how best to add 

indexing elements, FDA determined 

that the most efficient strategy is for 

FDA, not individual applicants, to index 

the SPL using a phased approach. We 

will index the pharmacological class 

during the first phase. We are adding 

pharmacologic class first because: (1) It 

is important for the safe use of drugs, (2) 

it is necessary for making future 

indexing meaningful (e.g., drug 

interactions), and (3) this choice 

leverages existing FDA resources. After 

pharmacologic class, we will be seeking 

public input on which indexing 

elements should be added in future 

phases. 

The draft guidance also recommends 

that applicants submit any questions 

regarding existing indexing, including 

any requests to add or revise an 

indexing element, to CDER 

(spl@fda.hhs.gov). Inquiries and 

requests will be forwarded to the 

appropriate FDA personnel who will 

consider them and make the appropriate 

change in the SPL. 

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 indexing SPL. 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 regarding this document. 

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. 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 either 

http://www.fda.gov/cder/guidance/ 

index.htm orhttp://www.fda.gov/ohrms/ 

dockets/default.htm. 


ycherry on PROD1PC64 with NOTICES
12808 Federal Register / Vol. 72, No. 52 / Monday, March 19, 2007 / Notices 

Dated: March 7, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4881 Filed 3–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2007–27492] 

Chemical Transportation Advisory 

Committee 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting. 

SUMMARY: The Chemical Transportation 

Advisory Committee (CTAC), its 

Subcommittees on Hazardous Cargo 

Transportation Security (HCTS), the 

National Fire Protection Association 

(NFPA) 472 Standard, and Outreach, as 

well as its Working Group on Barge 

Hazard Communication will meet to 

discuss various issues relating to the 

marine transportation of hazardous 

materials in bulk. These meetings will 

be open to the public. 

DATES: Both the Subcommittee on 

Outreach and the Working Group on 

Barge Hazard Communication will meet 

on Tuesday, April 10, 2007, from 8 a.m. 

to 12 p.m. and the NFPA 472 

Subcommittee will meet on Tuesday, 

April 10, 2007, from 12:30 p.m. to 4:30 

p.m. The NFPA 472 Subcommittee will 

meet on Wednesday, April 11, 2007, 

from 8 a.m. to 12 p.m. and the 

Subcommittee on HCTS will meet on 

Wednesday, April 11, 2007, from 12:30 

p.m. to 4:30 p.m. CTAC will meet on 

Thursday, April 12, 2007, from 9 a.m. to 

3:30 p.m. These meetings may close 

early if all business is finished. Written 

material and requests to make oral 

presentations should reach the Coast 

Guard on or before April 3, 2007. 

Requests to have a copy of your material 

distributed to each member of the 

Committee should reach the Coast 

Guard on or before April 3, 2007. 

ADDRESSES: The meetings of the 

Subcommittees on Outreach, NFPA 472 

and HCTS and the Working Group on 

Barge Hazard Communication will be 

held at the National Fire Protection 

Association, 1 Batterymarch Park, 

Quincy, MA 02269. The CTAC meeting 

will be held at the Boston Marriott 

Quincy, 1000 Marriott Drive, Quincy, 

MA 02269. Send written material and 

requests to make oral presentations to 

Commander Richard Raksnis, Executive 

Director of CTAC, Commandant (CG–

3PSO–3), U.S. Coast Guard 

Headquarters, 2100 Second Street SW., 

Washington, DC 20593–0001 or E-mail: 

CTAC@comdt.uscg.mil. This notice is 

available on the Internet at http:// 

dms.dot.gov. 

FOR FURTHER INFORMATION CONTACT: 

Commander Richard Raksnis, Executive 

Director of CTAC, or Ms. Sara Ju, 

Assistant to the Executive Director, 

telephone 202–372–1425, fax 202–372–

1926. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act, 5 

U.S.C. App. (Pub. L. 92–463). 

Agenda of the Outreach Subcommittee 

Meeting on Tuesday, April 10, 2007 

(1) Introduce Subcommittee members 

and attendees. 

(2) Finalize the poster presentation for 

the Responsible Care Conference in 

May, 2007. 

(3) Discuss outreach efforts on issues 

of barge emissions and vapor control 

systems. 

Agenda of the Barge Hazard 

Communication Working Group, April 

10, 2007 

(1) Introduce Working Group 

members and attendees. 

(2) Draft letter for voluntary 

compliance with the 24-hour contact 

number. 

(3) Develop future Working Group 

plans. 

Agenda of the NFPA 472 Subcommittee 

Meeting on Tuesday, April 10, 2007 

(1) Introduce Subcommittee members 

and attendees. 

(2) Complete first draft of proposed 

chapter describing competencies of 

responders to marine non-tank vessel 

incidents, for future incorporation into 

the NFPA 472 Standard, Professional 

Competence of Responders to 

Hazardous Materials Incidents. 

Agenda of the NFPA 472 Subcommittee 

Meeting on Wednesday, April 11, 2007 

(1) Introduce Subcommittee members 

and attendees. 

(2) Begin work on second draft of 

chapter describing competencies of 

responders to marine non-tank vessel 

incidents. 

(3) Discuss future plans for the 

Subcommittee. 

Agenda of the Subcommittee on 

Hazardous Cargo Transportation 

Security (HCTS) on Wednesday, April 

11, 2007 

(1) Introduce Subcommittee members 

and attendees. 

(2) Discussion on updates to the 

Maritime Transportation Security Act 

(MTSA) regulations. 

(3) Discuss Coast Guard Certain 

Dangerous Cargo (CDC) security project. 

Agenda of CTAC Meeting on Thursday, 

April 12, 2007 

(1) Introduce Committee members and 

attendees. 

(2) Status report presentation from the 

CTAC HCTS Subcommittee to include 

discussion and vote on comments to the 

MTSA regulations. 

(3) Status report presentation from the 

CTAC Outreach Subcommittee. 

(4) Status report presentation from the 

CTAC Barge Hazard Communication 

Working Group. 

(5) Status report presentation from the 

CTAC MARPOL Annex II Working 

Group. 

(6) Status report presentation from the 

NFPA 472 Subcommittee. 

(7) Presentation on the Transportation 

Worker Identification Credential (TWIC) 

Program. 

(8) Presentation on the Marine 

Chemist Program. 

(9) Presentation on LNG deepwater 

port issues. 

(10) Update on Coast Guard regulatory 

projects. 

Procedural 

These meetings are open to the 

public. Please note that the meetings 

may close early if all business is 

finished. At the discretion of the Chair, 

members of the public may make oral 

presentations during the meetings 

generally limited to five minutes. If you 

would like to make an oral presentation 

at a meeting, please notify the Executive 

Director and submit written material on 

or before April 3, 2007. If you would 

like a copy of your material distributed 

to each member of the Committee in 

advance of a meeting, please submit 25 

copies to the Executive Director (see 

ADDRESSES) no later than April 3, 2007. 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with 

disabilities, or to request special 

assistance at the meeting, telephone the 

Executive Director as soon as possible. 

Dated: March 8, 2007. 

J.G. Lantz, 

Director of National and International 

Standards, Assistant Commandant for 

Prevention. 

[FR Doc. E7–4935 Filed 3–16–07; 8:45 am] 

BILLING CODE 4910–15–P 


ycherry on PROD1PC64 with NOTICES