[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]
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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.
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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