Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices 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Draft Guidance for Industry on Allergic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availability of a draft guidance for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 This draft guidance is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draft guidance by September 19, 2000.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draft guidance are based on a careful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 The draft guidance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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1306]

Draft Guidance for Industry on the

Content and Format of the Adverse

Reactions Section of Labeling for

Human Prescription Drugs and

Biologics; 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 ‘‘Content and Format

of the Adverse Reactions Section of

Labeling for Human Prescription Drugs

and Biologics.’’ The agency has initiated

a comprehensive effort to improve the

content and format of prescription drug

labeling. This draft guidance is the first

in a series of guidance documents on

the content and format of individual

labeling sections. FDA intends to

carefully coordinate development and

implementation of these various

labeling initiatives to minimize the

potential burden for manufacturers and

other affected parties.

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 or at http://

www.fda.gov/cber/guidelines.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, or to the

Office of Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3844, FAX 888–CBERFAX, or Voice

Information System at 800–835–4709.

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:

Janet M. Jones, Center for Drug

Evaluation and Research (HFD–40),

Food and Drug Administration,