CONTENT AND FORMAT OF DATA SUBMISSIONS

586A REQUEST WITHDRAWAL

ADVISORY COMMITTEE PROCESS

Over-the-Counter (OTC) Sunscreens

Guidance Summary

Presented by: Sandeepkumar Balabbigari

March 11th 2016

Regulatory BackgroundThe Sunscreen Innovation Act (SIA) was

designed to amend the Food, Drug, and

Cosmetic Act to spur the review or approval

of OTC sunscreens

Sunscreens are regulated by either the:

• New drug approval process: products may not be

marketed without FDA’s prior review and approval

for each product

• OTC drug monograph process: active ingredients

that are determined to be GRASE in a final

sunscreen order may be marketed in a sunscreen

product without obtaining NDA or ANDA approval

Content and Format of

Data Submission

Purpose

Addresses the format and content of

data needed to support GRASE

determination of a single or a

combination of OTC sunscreen active

ingredient(s) in 586A requests

Industry RequirementsAll data and information relevant for GRASE

determination for each active ingredient in the

586A request should be provided in a single

submission using the format detailed in the

Common Technical Document (CTD)

Previously submitted data can be used for

GRASE determination but a copy of the

information must be identified and provided

in the current submission

Data should be made publicly available

Electronic submission are encouraged

Data Submission Modules

Module 1: Administrative Information

Module 2: Overview and Summary

of Modules 3 to 5

Module 3: Relevant Quality Information

Module 4: Preclinical Data

(Pharmacology/Toxicology)

Module 5: Clinical Safety and Efficacy

Module 1, 2, and 3Module 1: Administrative Information

• Labeling information

• Statements about confidential information

• Cover letter

• Financial disclosure

Module 2: Overview and Summary

of Modules 3 to 5

• Summaries of evidence that supports and does not

support that the active ingredient is GRASE

Module 3: Quality Data

• Active ingredient(s)’ current compendia status

• Chemical and manufacturing characteristics

Module 4 & 5Module 4: Preclinical Data

• Data and reports from nonclinical studies discussed

in the Safety and Efficacy Draft Guidance

• Any other types of nonclinical information

Module 5: Clinical Safety and Efficacy

• Comprehensive and integrated summaries of

effectiveness and clinical safety

• Full reports of all clinical effectiveness and safety

studies, clinical pharmacology and human

toxicokinetic data, and other clinical data from

other published materials

586A Request Withdrawal

Purpose

Addresses the process sponsors must

follow to withdraw a 586A request and

pending request

586A Request

Withdrawal Process

Sponsors seeking to withdraw a 586A request should

submit a written or electronic request to the docket

with a copy to the Division of Nonprescription Drug

Products in the Office of Drug Evaluation IV

Sponsors may request a withdrawal of their 586A

request during any point of the SIA process (initial

eligibility determination, data submission, filing

determination, GRASE determination)

FDA may withdraw a sponsor’s 586A request if the

sponsor fails to respond within 90 days of request for

information or data regarding the submission

Industry Requirements

Withdrawal request should include:

• Submitter

• Submission date

• Active ingredient/subject of the submission

• Docket number

Advisory Committee Process

Purpose

Provides an overview of the advisory

committee process and the convening of

the Nonprescription Drugs Advisory

Committee (NDAC)

Nonprescription Drugs Advisory

Committee (NDAC) OverviewEstablished under the Federal Advisory

Committee Act

Reviews and evaluates data concerning the

safety and effectiveness of OTC drug

products, advises FDA on monograph

requirements for GRASE determination

Consists of 10 voting members from various

areas of healthcare

May take 4 to 6 months to prepare for an

NDAC meeting

NDAC Requests

Sponsors can request FDA to convene

the NDAC to consider the issues related

to the sponsors’ 586A request

FDA may also convene the NDAC for

any 586A request regardless of whether

the sponsor has made a NDAC request

THANK YOU!

QUESTIONS?