[Federal Register Volume 66, Number 207 (Thursday, October 25, 2001)]
[Notices]
[Page 54018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26834]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Participants at the Process Analytical Technologies 
Subcommittee of the Advisory Committee for Pharmaceutical Science

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting names of 
qualified persons to participate on the Process Analytical Technologies 
Subcommittee (the Subcommittee) of the Advisory Committee for 
Pharmaceutical Science. The Subcommittee will identify and report to 
the Advisory Committee for Pharmaceutical Science on scientific issues 
related to application and validation of online process technologies 
such as near infrared and Raman spectroscopy and imaging methods for 
application in the manufacture of drug substances and drug products. 
The Subcommittee will also report on the potential benefits and risks 
associated with the application of these new technologies to public 
health and, as part of this analysis, evaluate the feasibility of the 
parametric release concept.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented and, 
therefore encourages recommendations of qualified candidates from these 
groups. Final selections from among qualified candidates will be based 
on the expertise demonstrated and previous experience with online 
process technologies.

DATES: All applications should be received by November 30, 2001.

ADDRESSES: Submit applications to David Morley (address below).

FOR FURTHER INFORMATION CONTACT: David Morley, Office of Testing and 
Research (HFD-900), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
5186, FAX 301-827-3787, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is seeking qualified persons to participate on the Process 
Analytical Technologies Subcommittee being formed under the Advisory 
Committee for Pharmaceutical Science. The Subcommittee will identify 
and report on the current state of technology, validation procedures, 
and the mechanistic basis of online process controls in both drug 
development and scaleup. These participants are not members of the 
Subcommittee and will not be voting on any issues, but they are 
encouraged to participate in the discussion of the issues. The 
Subcommittee will evaluate the potential for enhancing product quality 
and providing public health benefit.

II. Selection Criteria

    Persons from government, industry, academia, and other 
organizations (such as research institutes) applying to participate on 
the Subcommittee should have exceptional accomplishments and be leading 
technical experts in the appropriate fields. In particular, expertise 
in application of the following scientific disciplines to 
pharmaceutical development and pharmaceutical manufacturing processes 
is desired: Process analytical chemistry, pharmaceutics, industrial 
pharmacy, chemical engineering, pharmaceutical analysis, chemometrics, 
pattern recognition, computer expert systems, information technology, 
and statistics.

III. Application Procedures

    Any interested person should submit appropriate biographical 
material and a list of scientific publications relevant to the 
Subcommittee to the contact person listed above.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 17, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26834 Filed 10-24-01; 8:45 am]
BILLING CODE 4160-01-S