[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Page 38563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15632]



[[Page 38563]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1335]


Draft Guidance for Industry on Allergic Rhinitis: Clinical 
Development Programs for Drug Products; 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availability of a draft guidance for industry entitled ``Allergic 
Rhinitis: Clinical Development Programs for Drug Products.'' This draft 
guidance is intended to assist sponsors of new drug applications 
(NDA's) in designing development programs for oral and intranasal drug 
products for the treatment of allergic rhinitis in children and adults.

DATES: Submit written comments on the draft guidance by September 19, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 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 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 Submit written comments on the draft guidance 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.

FOR FURTHER INFORMATION CONTACT:  Martin H. Himmel, Center for Drug 
Evaluation and Research (HFD-570), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1050.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Allergic Rhinitis: Clinical 
Development Programs for Drug Products.'' Information about the 
pathophysiology and treatment of allergic rhinitis and its subtypes, 
seasonal allergic rhinitis (SAR), and perennial allergic rhinitis (PAR) 
has grown markedly in the past decade. The recommendations in this 
draft guidance are based on a careful assessment of important issues 
raised in the review of both adult and pediatric allergic rhinitis 
clinical trials and the agency's current understanding of the mechanism 
of the two related disorders of SAR and PAR. The draft guidance 
addresses issues of study design, data analysis, evaluation, and 
overall considerations for pediatric and adult trials.
    This draft guidance includes recommendations on patient selection, 
inclusion and exclusion criteria, choice of primary and secondary 
endpoints, statistical analysis, safety monitoring, evaluation of the 
onset of action, durability of effect, and prophylaxis trials. The 
draft guidance also discusses abbreviated development programs that may 
be conducted for a formulation or device change. When finalized, this 
draft guidance will replace the previous guidance document entitled 
``Points to Consider: Clinical Development Programs for New Nasal Spray 
Formulations'' (January 1996).
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on development programs for oral and 
intranasal drug products for the treatment of allergic rhinitis in 
children and adults. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments 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 and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15632 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F