62068 Federal Register / Vol. 69, No. 204 / Friday, October 22, 2004 / Notices 

Drug—Specific Safety Concerns (all 

studies):

1. It is unknown whether azithromycin has 

an adverse events profile similar to or 

different than that reported for erythromycin, 

with respect to infantile hypertrophic pyloric 

stenosis. 

2. Colonization and infection with other 

bacterial (including macrolide-resistant 

organisms) and non-bacterial organisms (e.g.

fungus) may occur with azithromycin 

treatment. 

3. Macrolides have been associated with 

hearing loss at high doses. The potential for 

hearing loss with azithromycin treatment in 

this population will be assessed. 

Safety (all studies): Safety assessments will 

include occurrence of any adverse events 

(AEs), incidence of superinfections 

(particularly fungal infections), vital signs 

that include heart rate , blood pressure, 

respiratory rate , pulse oximetry, standard 

laboratory assessments of hematologic, liver 

and renal function, assessments of hearing, 

and growth (weight, length and head 

circumference). AEs will be followed to their 

resolution or stabilization. Nosocomial 

infection will be tracked by pathogen. 

Drug Information:

• Dosage Form: approved age appropriate 

oral formulations of azithromycin and 

erythromycin Route of Administration: oral 

• Regimen: To be determined 

Selection of doses for azithromycin in 

Study 1 will be guided by extrapolation of 

data from azithromycin use in older infants, 

published literature and/or current medical 

practice. Azithromycin doses chosen for 

Study 2 will be guided by the results of 

Study 1. For Studies 1 and 2, erythromycin 

dose will be based on current medical 

practice. Selection of azithromycin doses for 

Study 3 will be guided by the results of 

Studies 1 and 2. Azithromycin doses for 

Study 4 will be guided by the results of the 

first three studies. 

Labeling that may result from the studies:

Appropriate sections of the label may be 

changed to incorporate the findings of the 

studies. 

Format of reports to be submitted: Full 

study reports not previously submitted to the 

Agency addressing the issues outlined in this 

request, with full analysis, assessment, and 

interpretation are required. Pharmacokinetic 

study reports will include analytical method 

and assay validation, individual drug 

concentration-time data and individual 

pharmacokinetic parameters (and 

pharmacodynamic data when available). In 

addition, the reports are to include 

information on the representation of 

pediatric patients of ethnic and racial 

minorities. All pediatric patients enrolled in 

the studies should be categorized using one 

of the following designations for race: 

American Indian or Alaska Native, Asian, 

Black or African American, Native Hawaiian 

or other Pacific Islander or White. For 

ethnicity, one of the following designations 

must be used: Hispanic/Latino or Not 

Hispanic/Latino. 

Response to Written Request: As per the 

Best Pharmaceuticals for Children Act, 

Section 3, if we do not hear from you within 

30 days of the date of this Written Request, 

we will refer this Written Request to the 

Director of the NIH. If you agree to the 

request, then you must indicate when the 

pediatric studies will be initiated. 

Please submit protocols for the above 

studies to an investigational new drug 

application (IND) and clearly mark your 

submission ‘‘PEDIATRIC PROTOCOL 

SUBMITTED IN RESPONSE TO WRITTEN 

REQUEST’’ in large font, bolded type at the 

beginning of the cover letter of the 

submission. Please notify us as soon as 

possible if you wish to enter into a written 

agreement by submitting a proposed written 

agreement. Clearly mark your submission 

‘‘PROPOSED WRITTEN AGREEMENT FOR 

PEDIATRIC STUDIES’’ in large font, bolded 

type at the beginning of the cover letter of the 

submission. 

Reports of the studies should be submitted 

as a new drug application (NDA) or as a 

supplement to an approved NDA with the 

proposed labeling changes you believe would 

be warranted based on the data derived from 

these studies. When submitting the reports, 

please clearly mark your submission 

‘‘SUBMISSION OF PEDIATRIC STUDY 

REPORTS—COMPLETE RESPONSE TO 

WRITTEN REQUEST’’ in large font, bolded 

type at the beginning of the cover letter of the 

submission and include a copy of this letter. 

If you wish to discuss any amendments to 

this Written Request, please submit proposed 

changes and the reasons for the proposed 

changes to your application. Submissions of 

proposed changes to this request should be 

clearly marked ‘‘PROPOSED CHANGES IN 

WRITTEN REQUEST FOR PEDIATRIC 

STUDIES’’ in large font, bolded type at the 

beginning of the cover letter of the 

submission. You will be notified in writing 

if any changes to this Written Request are 

agreed upon by the Agency. 

We hope you will fulfill this pediatric 

study request. We look forward to working 

with you on this matter in order to develop 

additional pediatric information that may 

produce health benefits in the pediatric 

population.

[FR Doc. 04–23724 Filed 10–21–04; 8:45 am] 

BILLING CODE 4167–01–P

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[FEMA–1545–DR] 

Florida; Amendment No. 11 to Notice 

of a Major Disaster Declaration

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security.

ACTION: Notice.

SUMMARY: This notice amends the notice 

of a major disaster for the State of 

Florida (FEMA–1545–DR), dated 

September 4, 2004, and related 

determinations.

EFFECTIVE DATE: October 8, 2004.

FOR FURTHER INFORMATION CONTACT:

Magda Ruiz, Recovery Division, Federal 

Emergency Management Agency, 

Washington, DC 20472, (202) 646–2705.

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the incident period for 

this disaster is closed effective October 

8, 2004.

(The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund Program; 97.032, Crisis 

Counseling; 97.033, Disaster Legal Services 

Program; 97.034, Disaster Unemployment 

Assistance (DUA); 97.046, Fire Management 

Assistance; 97.048, Individuals and 

Households Housing; 97.049, Individuals and 

Households Disaster Housing Operations; 

97.050 Individuals and Households 

Program—Other Needs; 97.036, Public 

Assistance Grants; 97.039, Hazard Mitigation 

Grant Program)

Michael D. Brown, 

Under Secretary, Emergency Preparedness 

and Response, Department of Homeland 

Security.

[FR Doc. 04–23733 Filed 10–21–04; 8:45 am] 

BILLING CODE 9110–10–P

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[FEMA–1561–DR] 

Florida; Amendment No. 5 to Notice of 

a Major Disaster Declaration

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security.

ACTION: Notice.

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

State of Florida (FEMA–1561–DR), 

dated September 26, 2004, and related 

determinations.

EFFECTIVE DATE: October 14, 2004.

FOR FURTHER INFORMATION CONTACT:

Magda Ruiz, Recovery Division, Federal 

Emergency Management Agency, 

Washington, DC 20472, (202) 646–2705.

SUPPLEMENTARY INFORMATION: The notice 

of a major disaster declaration for the 

State of Florida is hereby amended to 

include the following areas among those 

areas determined to have been adversely 

affected by the catastrophe declared a 

major disaster by the President in his 

declaration of September 26, 2004:

Collier, Lee, and Miami-Dade Counties for 

emergency protective measures (Category 

B) under the Public Assistance program.