[Federal Register Volume 64, Number 121 (Thursday, June 24, 1999)]
[Notices]
[Page 33869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16140]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-1738]


Draft Guidance for Industry on Bioavailability and Bioequivalence 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availability of a draft guidance for industry entitled 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 This draft guidance document provides 
recommendations to applicants intending to provide studies to document 
bioavailability (BA) or bioequivalence (BE) in support of new drug 
applications (NDA's), or abbreviated new drug applications (ANDA's) for 
locally acting nasal aerosols (metered-dose inhalers) and nasal sprays 
(metered-dose spray pumps).

DATES: Written comments on the draft guidance document may be submitted 
by September 22, 1999. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm''. Submit written 
requests for single copies of the draft guidance for industry to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send one-self addressed adhesive label to assist the 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 Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 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.

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: 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draft guidance for industry entitled ``Bioavailability and 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 This draft guidance provides recommendations to applicants 
intending to provide studies to document BA or BE in support of NDA's 
or ANDA's for locally acting nasal aerosols and nasal sprays. This 
guidance covers prescription corticosteroids, antihistamines, 
anticholinergic drug products, and the over-the-counter (OTC) mast-cell 
stabilizer cromolyn sodium. This guidance does not cover studies of 
nasal sprays included in applicable OTC monographs or studies of: (1) 
Metered-dose products intended to deliver drug systemically via the 
nasal route, or (2) drugs in nasal nonmetered dose atomizer (squeeze) 
bottles that require premarket approval.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents 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 statute, 
regulations, or both.
    Interested persons may, on or before September 22, 1999, submit to 
the Dockets Management Branch (address above) written comments with 
evidence to support or refute approaches on the draft guidance. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The draft guidance 
document and received comments may be seen in the office above between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 16, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-16140 Filed 6-23-99; 8:45 am]
BILLING CODE 4160-01-F