[Federal Register: April 3, 2003 (Volume 68, Number 64)]
[Notices]
[Page 16292-16293]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap03-72]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1738]
Draft Guidance for Industry: Bioavailability and Bioequivalence
Studies for Nasal Aerosols and Nasal Sprays for Local Action;
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availability of a draft guidance for industry entitled
``Bioavailability and Bioequivalence Studies for Nasal Aerosols and
Nasal Sprays for Local Action.'' This draft document provides
recommendations to applicants planning product quality studies to
document bioavailability (BA) or bioequivalence (BE) in support of new
drug applications (NDAs), or abbreviated new drug applications (ANDAs)
for locally acting drugs in nasal aerosols (metered-dose inhalers) and
nasal sprays (metered-dose spray pumps). The draft guidance was
originally issued for comment on June 24, 1999. Since many substantive
changes have been made to the guidance, it is being reissued for
comment as a level 1 draft guidance.
DATES: Submit written or electronic comments on the draft guidance by
July 2, 2003. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance for industry to the Division of Drug Information (HFD-240),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 self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the draft guidance to the Dockets Management
Branch (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section for electronic access to the draft guidance document.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: Wallace P. Adams, Center for Drug
Evaluation and Research (HFD-350), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5651.
SUPPLEMENTARY INFORMATION:
[[Page 16293]]
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Bioavailability and Bioequivalence Studies for Nasal
Aerosols and Nasal Sprays for Local Action.'' This draft guidance
provides recommendations to applicants planning product quality studies
to document BA or BE in support of NDAs or ANDAs for locally acting
drugs in nasal aerosols and nasal sprays. This guidance addresses BA
and BE studies of prescription corticosteroids, antihistamines,
anticholinergic drug products, and the over-the-counter (OTC) mast-cell
stabilizer cromolyn sodium. The guidance does not address studies of
nasal sprays included in applicable OTC monographs or studies of: (1)
Metered-dose products intended to deliver drugs systemically via the
nasal route, or (2) drugs in nasal nonmetered dose atomizer (squeeze)
bottles that require premarket approval.
Because many substantive changes were made to the guidance after it
issued in 1999, the guidance is being reissued at this time for comment
as a level 1 draft guidance. We encourage applicants to submit any
evidence that supports or refutes the approaches outlined in this
guidance to the docket number given in brackets in the heading of this
document.
The changes made were based on the following: (1) Public comments
submitted to the original docket, (2) the outcome of April 2000 and
July 2001 meetings of the Orally Inhaled and Nasal Drug Products
Subcommittee of the FDA Advisory Committee for Pharmaceutical Science
(ACPS), (3) a July 2001 meeting of the ACPS, and (4) internal
discussions within the Center for Drug Evaluation and Research. Changes
include reduction in the recommended extent of in vitro testing,
elimination of two of the three options for rhinitis study design, and
elimination of the recommendation to demonstrate a dose-response
relationship from the recommended rhinitis study design (traditional 2-
week study). The latter two changes are based on ACPS recommendations.
A section on reserve samples for BA and BE testing has also been added.
The statistical information that was previously part of the original
draft has now been consolidated into appendices that will be published
at a later date.
This level 1 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 BA and
BE product quality information related to nasal inhalation aerosols and
nasal metered-dose spray pumps. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public.
Alternative approaches to documentation of BA and BE may be used if
such approaches satisfy the requirements of the applicable statutes and
regulations.
II. Comments
Interested persons may submit to the Dockets Management Branch
written or electronic comments regarding this document. Submit a single
copy of electronic comments to http://www.fda.gov/dockets/ecomments or
two hard copies of any written comments, except that individuals may
submit one hard copy. Comments are to be indentified with the docket
number found in brackets in the heading of this document. The draft
guidance and received comments may be seen in the Dockets Management
Branch 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 or http://
www
Dated: March 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8010 Filed 4-2-03; 8:45 am]
BILLING CODE 4160-01-S