[Federal Register Volume 66, Number 78 (Monday, April 23, 2001)]
[Notices]
[Pages 20467-20468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9949]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Studies of Adverse Effects of Marketed Drugs; Availability of 
Grants (Cooperative Agreements); Request for Applications; Correction

AGENCY: Food and Drug Administration, HHS.

[[Page 20468]]


ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of April 4, 2001 (66 FR 17907). 
The document announced the anticipated availability of funds for 
cooperative agreements to study adverse affects of drugs marketed in 
the United States and its territories. The document was published with 
some inadvertent errors. This document corrects those errors.

DATES: Submit applications by June 4, 2001.

ADDRESSES: Application kits are available from, and completed 
applications should be submitted to Rosemary T. Springer, Division of 
Contracts and Procurement Management (HFA-520), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7182.
    Note: Applications hand-carried or commercially delivered should be 
addressed to 5630 Fishers Lane, rm. 2129, Rockville, MD 20852. Please 
DO NOT send applications to the Center for Scientific Review (CSR), 
National Institutes of Health. Applications mailed to CSR and not 
received by FDA in time for orderly processing will be returned to the 
applicant without consideration. Application forms can also be found at 
http://www.nih.gov/grants/phs398/forms-toc.html.

FOR FURTHER INFORMATION CONTACT: Rosemary T. Springer, Division of 
Contracts and Procurement Management (HFA-520), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7182.

SUPPLEMENTARY INFORMATION: In FR Doc. 01-8246, appearing on page 17907 
in the Federal Register of Wednesday, April 4, 2001, the following 
corrections are made:
    1. On page 17910, in the first column, section VI.B.1.b is 
corrected to read as follows:
    b. Size (70 points). Applicants should list number of patients 
enrolled in their database as of December 31, 2000.
     >3 million covered lives (70 points)
     >2.5 to 3 million covered lives (40 points)
     >2 to 2.5 million covered lives (30 points)
     >1.5 to 2 million covered lives (10 points)
    2. On page 17910, in the first column, section VI.B.1.c is 
corrected to read as follows:
    c. Duration (55 points). The calender time-period for which 
detailed patient longitudinal data are available and linked for 
routine, day-to-day analysis from at least 80 percent of the multiple 
State sites.
     5 years of data online (0 points)
     5 years of data online (25 points)
     6 points for each additional year beyond 5 years of online 
data to a possible total of 55 points
    3. On page 17910, in the third column, section VI.B.2. is corrected 
to read as follows:
2. New Molecular Entity (NME) Identification (200 points)
    In table 1 of this document, 40 recently approved NMEs are listed. 
Applicants should respond with the number of unique patients in their 
system with at least 1 outpatient prescription for each of the 40 drug 
products listed in table 1. For each drug, points will be awarded by 
the review panel according to the following schedule:
     >25,000 exposed patients (5 points)
     20,001 to 25,000 exposed patients (4 points)
     15,001 to 20,000 exposed patients (3 points)
     10,001 to 15,000 exposed patients (2 points)
     5,001 to 10,000 exposed patients (1 point)
     5,000 or fewer exposed patients (0 points).

    Dated: April 17, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-9949 Filed 4-20-01; 8:45 am]
BILLING CODE 4160-01-S