[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]
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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Draft Guidance for Industry on Bioavailability and Bioequivalence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.
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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availability of a draft guidance for industry entitled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 This draft guidance document provides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DATES: Written comments on the draft guidance document may be submitted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ADDRESSES: Copies of this draft guidance are available on the Internet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requests for single copies of the draft guidance for industry to the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 Submit written comments on the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug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draft guidance for industry entitled ``Bioavailability and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 This draft guidance provides recommendations to applicants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]
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