12806 Federal Register / Vol. 72, No. 52 / Monday, March 19, 2007 / Notices 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

All records are stored on magnetic 

media. 

RETRIEVABILITY: 

All Medicare records are accessible by 

HIC number or alpha (name) search. 

This system supports both online and 

batch access. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: The Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: All pertinent NIST 

publications; the HHS Automated 

Information Systems Security Handbook 

and the CMS Information Security 

Handbook. 

RETENTION AND DISPOSAL: 

• ‘‘Records will be retained until an 

approved disposition authority is 

obtained from the National Archives 

and Records Administration.’’

SYSTEM MANAGER AND ADDRESS: 

Director, Survey and Certification 

Group, Center for Medicaid and State 

Operations, CMS, 7500 Security 

Boulevard, Baltimore, Maryland 21244–

1850. 

NOTIFICATION PROCEDURE: 

For purpose of access, the subject 

individual should write to the system 

manager who will require the system 

name, health insurance claim number, 

address, date of birth, and sex, and for 

verification purposes, the subject 

individual’s name (woman’s maiden 

name, if applicable), and social security 

number (SSN). Furnishing the SSN is 

voluntary, but it may make searching for 

a record easier and prevent delay. 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

department regulation 45 CFR 5b.5 (a) 

(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

department regulation 45 CFR 5b.7). 

RECORD SOURCE CATEGORIES: 

The data contained in these records 

are furnished by the individual, or in 

the case of some MSP situations, 

through third party contacts. There are 

cases, however, in which the identifying 

information is provided to the physician 

by the individual; the physician then 

adds the medical information and 

submits the bill to the carrier for 

payment. Updating information is also 

obtained from the Railroad Retirement 

Board, and the Master Beneficiary 

Record maintained by the Social 

Security Administration. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. E7–4889 Filed 3–16–07; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. The committee 

also advises and makes 

recommendations to the Secretary of 

Health and Human Services under 21 

CFR 50.54 and 45 CFR 46.407 on 

research involving children as subjects 

that is conducted or supported by the 

Department of Health and Human 

Services, when that research is also 

regulated by FDA. 

Date and Time: The meeting will be 

held on April 11, 2007, from 4 p.m. to 

6 p.m. 

Location: Advisory Committee 

Conference Room, rm. 1066, 5630 

Fishers Lane, Rockville, MD. 

Contact Person: Carlos Pena, Office of 

Science and Health Coordination, Office 

of the Commissioner (HF–33), Food and 

Drug Administration, 5600 Fishers 

Lane, (for express delivery, rm. 14B–08), 

Rockville, MD 20857, 301–827–3340, email: Carlos.Pena@fda.hhs.gov or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732310001. Please call the Information 

Line for up to date information on this 

meeting. 

Agenda: The Pediatric Advisory 

Committee will hear and discuss reports 

by the agency, as mandated in section 

17 of the Best Pharmaceuticals for 

Children Act, on adverse event reports 

for fluvastatin (LESCOL) and octreotide 

(SANDOSTATIN). The committee will 

also receive updates to adverse event 

reports for orlistat (XENICAL) and 

oxybutynin (DITROPAN) which were 

requested by the Pediatric Advisory 

Committee when the reports were first 

presented. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 


ycherry on PROD1PC64 with NOTICES
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