[Federal Register Volume 68, Number 64 (Thursday, April 3, 2003)]
[Notices]
[Pages 16292-16293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8010]


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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Draft Guidance for Industry: Bioavailability and Bioequivalence 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.

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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availability of a draft guidance for industry entitled 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 The draft guidance was 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comment as a level 1 draft guidance.

DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance for industry to the Division of Drug Information (HFD-240), 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Submit written comments on the draft guidance to the Dockets Management 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section for electronic access to the draft guidance document.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.fda.gov/ohrms/dockets/default.htm.

    Dated: March 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8010 Filed 4-2-03; 8:45 am]
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